GIMBEL EYE CENTRE. Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE Last revised April 2013

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1 GIMBEL EYE CENTRE Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 Last revised April 2013 CALGARY: Toll-free EDMONTON: Toll-free gimbel.com

2 Table of Contents If you are reading a digital format, you can click on the bolded headings to jump to that section of the guide. Introduction...4 Meet our Doctors...5 Meet our Calgary Doctors...5 Meet our Edmonton Doctors...5 Contact Information...6 The Role of the Co-Managing Eyecare Provider...7 Pre-Operative Evaluation...7 Referrals to Gimbel Eye Centre...7 Post-Operative Evaluations...7 Corneal Refractive Surgery Descriptions...8 IntraLase Laser Assisted In Situ Keratomileusis (IntraLASIK)...8 Photo Refractive Keratectomy (PRK)...8 Photo Therapeutic Keratectomy (PTK)...8 Astigmatic Keratotomy (AK)...8 Laser Technology and Wavefront Treatment...8 Corneal Refractive Surgery Patient Selection...9 Eligibility Criteria for Corneal Refractive Surgery...9 Contraindications for Corneal Refractive Surgery...10 Corneal Refractive Surgery Post Operative Care...11 Postoperative Medication and Follow Up Regimen...11 PRK Post-Operative Extended Medication Protocol...12 Corneal Surgery Post Operative Presentation and Activity Restrictions...13 Corneal Refractive Surgery Complications and Treatment...14 Phakic IOL Refractive Surgery Descriptions...16 Implantable Collamer Lenses (ICL)...16 Angle Supported Phakic IOL (Cachet)...16 gimbel.com 2 Printed in Canada 2013

3 Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 Phakic IOL Surgery Patient Selection...17 Eligibility Criteria for Phakic IOL Surgery...17 Contraindications for Phakic IOL Surgery...17 Phakic IOL Postoperative Care...18 Postoperative Medication and Follow Up Regimen...18 Phakic IOL Post Operative Presentation and Activity Restrictions...19 Phakic IOL Postoperative Evaluation Considerations...20 Phakic IOL Surgery Complications and Treatment...21 Refractive Lens Exchange/Cataract Extraction Descriptions...22 Surgery Description...22 Alberta Health Care (AHC) Covered Services...22 Refractive Lens Exchange and Cataract Surgery Patient Selection...23 Refractive Lens Exchange/Cataract Surgery Lifestyle Implant Choices...24 Refractive Lens Exchange/Cataract Surgery Post Operative Care...25 Refractive Lens Exchange and Cataract Surgery Post Operative Medications and Follow up...25 Refractive Lens Exchange and Cataract Surgery Post Operative Presentations and Activity Restrictions...26 Refractive Lens Exchange/Cataract Surgery Complications and Treatment...27 Collagen Cross Linking Description...28 Accelerated Collagen Cross Linking Patient Selection...29 Presbyopia, Monovision and the Role of the Co-managing Doctor...30 Special Considerations in Refractive Surgery...31 Fee Information...32 Frequently Asked Questions...33 Forms...34 Last Revised April gimbel.com

4 Introduction Dear Doctor, Welcome to our new and updated Co-management guide! Since 1964, Gimbel Eye Centre has been providing Refractive and Cataract surgical options in a convenient, compassionate, and caring manner to our mutual patients. As an established ophthalmic surgery practice, we pride ourselves in providing honest, high quality care and realize that our success lies in the company we keep. We are very aware that the relationship with our co-managing Doctors is an integral part of our success. As we are committed to reinforcing your role as the Primary Eye Care Provider, we provide the convenience of collecting your co-management fees at the time of their surgery payment, and then pass it along to you. This promotes patient compliance, and emphasizes the importance of the patient returning to you for proper follow up care and beyond. In recognizing that our Associated Eyecare Providers may have different practice needs, we can deduct from your patient s surgery fees to enable you to charge your patient directly for follow up care based on your own fee schedule. Our goal with this new Co-management guide is to provide a concise, easy-to-reference resource to enable the busy practitioner to feel confident and up-to-date in our quickly evolving professions. Included are surgery descriptions, eligibility criteria, post-operative care, complication management, and fee structures. This resource is available in digital format and hard copy. In addition to the Co-management guide, Gimbel Eye Centre provides numerous other resources including YouTube videos with over 100 hours of intraocular surgery footage, our updated Website at complimentary Continuing Education Seminars regarding a wide range of ophthalmic surgery topics, and periodic Webinars and Webcasts. We welcome an open dialogue with our team of surgeons, optometrists, and staff, to support both you and your patient in this important life experience. We would be pleased to have you visit our Calgary or Edmonton Centre, and perhaps observe a surgery or two! Thanks for sharing our vision of providing the best eye care solutions for our mutual patients. Sincerely, Gimbel Eye Centre Team gimbel.com 4 Printed in Canada 2013

5 Meet our Doctors Meet our Calgary Doctors Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 H.V. Gimbel, MD, MPH, FRCSC, AOE, FACS, CABES Executive Medical Director Jacinthe Kassab, MD, FRCSC Associate Medical Director, Clinical Services John van Westenbrugge, MD, FRCSC Associate Medical Director, Surgical Services Marcella LaBelle BSc OD Mona Purba BSc OD Zenur Khan MSc OD Leta Theissen BSc OD Meet our Edmonton Doctors Geoffrey B Kaye, MB, ChB. FCS(SA), FRCSC Executive Medical Director, Gimbel Eye Centre, Edmonton Nohad Teliani BSc OD Last Revised April gimbel.com

6 Contact Information Office Addresses Gimbel Eye Centre CALGARY Market Mall Executive Professional Centre 450, th Avenue NW Calgary, Alberta T3A 2N1 Office Telephone Numbers (403) (800) Office Fax Numbers (403) Manager, Operations Lynda Kelly, COMT Gimbel Eye Centre EDMONTON Mira Health Centre 140, th Avenue Edmonton, Alberta T5G 0E5 Office Telephone Numbers (780) (888) Office Fax Numbers (780) Manager, Operations Violet Wray, LPN Your Contact Person Glenn Gimbel, President (403) gimbel.com 6 Printed in Canada 2013

7 Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 The Role of the Co-Managing Eyecare Provider As the Primary Eyecare provider, your role is important in the patient s Refractive Surgery journey, from beginning to end. Pre-Operative Evaluation A full eye examination including complete ocular and health history, refractive status, and dilated ocular health evaluation is recommended prior to referring the patient to our Centre. This is advantageous to the patient because we can pre-screen the referral and handle/discuss any issues prior to the patient s arrival for Gimbel Eye Centre assessment. This is advantageous to you because it establishes your participation in the patient s experience and encourages the patient to return to you for follow up care and beyond. The data collected in your referral will be carefully evaluated in conjunction with a complete Gimbel Eye Centre assessment to maximize accuracy and repeatability in the data used for surgery purposes. There is historical precedence that it is both the Refractive Surgery Centre s and the Primary Eyecare Provider s responsibility to ensure adequate informed consent surrounding the risks and benefits of refractive surgery, including presbyopia considerations and monovision. Refractions: For refractive surgery purposes: it is recommended to maximize the cyl and minimize the sphere component as this increases the odds of achieving emmetropia. Visual Acuity: For testing standardization, we request measurements up to 20/15. Referrals to Gimbel Eye Centre Pre-Operative Surgery Assessment Referral Forms (provided in this guide) can be forwarded via fax or . Our Patient Counselor will then contact the patient directly to make arrangements for a Gimbel Eye Centre preoperative assessment, surgery, and 1-day post-operative follow-up. A few things to be aware of in referring your patients: For All Surgery Types: The patient is required to discontinue soft contact lens wear for a minimum of 48 hours prior to testing at Gimbel Eye Centre, or 2 weeks for RGP contact lenses. For Potential Phakic IOL candidates: The patient should be prepared for two days of pre-operative testing at Gimbel Eye Centre and should make their travel arrangements accordingly. Post-Operative Evaluations After the patient s 1-day follow up visit, we encourage the patient to return to you for their follow up care. A report will be sent to you indicating type of surgery performed and the patient s current vision status. Follow up frequency and testing will be outlined in each section of this guide. A Post-Operative Follow Up Referral form (provided in this guide) should be sent to Gimbel Eye Centre for review, and a response will be returned if requested. We are happy to reassess the patient upon your request at no additional fee. Please be advised that due to processing times, it may be several weeks before you receive co-management fees. Last Revised April gimbel.com

8 Corneal Refractive Surgery Descriptions IntraLase Laser Assisted In Situ Keratomileusis (IntraLASIK). There are two lasers used in this procedure. The IntraLase Femtosecond Laser creates a flap by introducing focused energy, which creates a CO2 bubble in between the corneal layers. The laser then creates the laser flap edge by cutting around the perimeter, leaving a superior hinge. This advanced method of flap creation avoids most of the risks of using a mechanical microkeratome blade, reducing post-operative complications such as dryness, providing better contrast sensitivity, and creating an optimal stromal bed surface. Once the flap is lifted, the Nidek Excimer Laser EC5000 CXIII re-contours the corneal surface by ablating tissue to correct the refractive error and minimizing higher order aberrations. If IntraLASIK Xtra was chosen, the KXL collagen cross linking procedure is performed (see KXL Collagen Cross linking section). The surgeon replaces the flap, taking care to ensure good flap position and adherence. Photo Refractive Keratectomy (PRK) The surgeon loosens the corneal epithelium with an alcohol-based chemical solution and gently removes the epithelial cells. The Nidek Excimer Laser EC5000 CXIII re-contours the corneal surface by ablating tissue to correct the refractive error and minimizing higher order aberrations. If PRK Xtra was chosen, the KXL collagen cross linking procedure is performed (see KXL Collagen Cross linking section). The surgeon inserts a bandage contact lens. Photo Therapeutic Keratectomy (PTK) This procedure is not a refractive surgery in that it is done therapeutically, primarily for corneal conditions such as scarring, haze, or recurrent corneal erosion. It is similar to PRK as described above, except the surgeon limits the laser tissue ablation to the pathology or higher order aberrations being treated and stops once sufficient pathological tissue has been removed. The surgeon then inserts a bandage contact lens and healing will be similar to PRK. Astigmatic Keratotomy (AK) This procedure is generally done in conjunction with Intraocular surgery such as cataract surgery, and is done to reduce minor amounts of corneal astigmatism. The surgeon strategically creates a partial thickness peri-limbal incision. The length of the incision influences the amount of flattening of the steepest corneal meridian. Laser Technology and Wavefront Treatment All patients at Gimbel Eye Centre undergo wavefront analysis, which measures the Higher Order Aberrations of the entire eye. Factors affecting Higher Order Aberrations include refractive error, corneal abnormalities (such as scars), and lenticular changes, which can impact the quality of the vision. The standard laser treatment for all Gimbel Eye Centre patients is an aspheric, wavefront-optimized treatment. In addition, our surgeons use Active Tracker technology to follow the eye s movements during laser treatment, and Torsion Error Detection to compensate for natural rotation of the eye while lying down. Iris recognition technology is used, which takes the OPD scan iris information to align the cylinder treatment axis at surgery. gimbel.com 8 Printed in Canada 2013

9 Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 Corneal Refractive Surgery Patient Selection Eligibility Criteria for Corneal Refractive Surgery* Type of Surgery Refractive Range Healing Time/Time off Work Other Considerations PRK to -8.00D to +2.00D cyl -0.50D to -4.00D 7-10 days healing 1 week off work 3 days discomfort adequate pachymetry acceptable corneal topography may be preferred for certain occupations (police) ease of enhancement PTK any 7-10 days healing 1 week off work 3 days discomfort reserved for corneal pathologies such as scars, haze, or recurrent corneal erosion, higher order aberrations IntraLASIK to -8.00D to +2.00D cyl -0.50D to -4.00D 3-5 days 3 days off work minimal discomfort adequate pachymetry acceptable corneal topography consider rare risk of flap dislodgement AK cyl -0.50D to -2.00D Must have spherical equivalent of almost plano if this is a primary surgery orthogonal cylinder axis. 1-2 days healing minimal discomfort less predictable than other refractive surgery options acceptable corneal topography often done in conjunction with other procedures, thus post operative medications are those of the primary surgery. * The patient should be at least 18 years of age, not pregnant or nursing, with at least 12 months of stable refractions (within +/-0.50D). Last Revised April gimbel.com

10 Corneal Refractive Surgery Patient Selection Contraindications for Corneal Refractive Surgery Category Condition Comments Ocular Pathology Corneal scar PRK may be preferred due to risk of flap complication Systemic Pathology Endothelial Dystrophy Map Dot Fingerprint Dystrophy and/or Recurrent Corneal Erosion Herpes Simplex/Zoster with history of ocular involvement Lid Disease i.e. Blepharitis Extreme Dry Eyes Binocular Dysfunction Amblyopia (BCVA <20/40) Nystagmus Other i.e. macular degeneration, retinal holes or tears Autoimmune Disorders: rheumatoid arthritis, Sjogren s syndrome, Lupus Gastrointestinal Disorders: Ulcerative Colitis, Crohn s Disease, Irritable Bowel Syndrome Diabetes Immuno-compromised patients: HIV, AIDS, Hepatitis PRK may be preferred due to risk of endothelial cell damage with flap creation PRK may be preferred due to weak Bowman s layer Considered on a case-by-case basis due to risk of re-activation Must be pre-treated due to risk of infiltrates/ infection Considered on a case-by-case basis Phakic IOLs may be preferred If prism required in glasses and/or pt experiences diplopia/headaches with contact lenses, then there may be a risk of decompensation after surgery and may require glasses with prism after surgery. Pt must understand the risks/implications of doing surgery when one eye is already weak Considered on a case-by-case basis. Consider challenges in eye stability during the surgical procedure. Priority will be given to the pathology first. Consider potential vision loss due to surgery. Considered on a case-by-case basis due to risk of corneal melt Phakic IOLs may be preferred Considered on a case-by-case basis due to risk of inflammatory reaction. Must be in remission. Phakic IOLs may be preferred Must not have any retinopathy, and blood sugar levels should be controlled. Consider infection risk. Prefer that the patient is on HART therapy and the virus is not detectable in the blood. Consider infection risk. For Hep B or C, consider risk of transmission. Medications Accutane, Clarus Must be off this medication for 6 months prior to surgery due to risk of severe dryness gimbel.com 10 Printed in Canada 2013

11 Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 Corneal Refractive Surgery Post Operative Care Postoperative Medication and Follow Up Regimen Type of Corneal Surgery Medication/Treatment Protocol Follow Up Schedule IntraLASIK PRK/PTK Prednisolone 1.0% qid x 7 days Vigamox 0.5% qid x 7 days then stop Artificial Tears: q15-30 minutes during waking hours x 2 days, then prn Celluvisc for first 4 sleeps, then prn Eye Shields: First 5-7 nights to protect the eyes/ maintain hydration Vigamox 0.5% qid x 7 days then stop Gabapentin 300 mg p.o. tid x 3 days okay to use Advil or Tylenol in conjunction with Gabapentin if needed FML 0.1% qid x 1 month minimum (see Extended Medication Protocol next page) Nevanac 0.1% qid on day of surgery then prn up to qid for the first week Tetracaine 0.5% last resort pain eye drop prn, used sparingly Artificial tears q15-30 minutes-waking hours until contact lens is removed then prn Celluvisc for first 4 sleeps, then prn Eye Shields: First 5-7 nights to protect the eyes/ maintain hydration Bandage Contact Lens: To be removed after re-epithelialization, with forceps, by Doctor Day 1, Week 1, Month 1 Then yearly eye examinations Day1, Day 3, Week 1, Month 1, Then monthly until 1 month after FML is discontinued, then yearly eye examinations * Additional visits should be performed as deemed clinically necessary. The post operative co-management fee includes the first 12 months of follow up, not including the yearly eye examination. Last Revised April gimbel.com

12 PRK Post-Operative Extended Medication All patients require FML qid for the first month. Taper regimen is based upon primary preoperative refraction. For patients having an enhancement, the taper regimen is determined by the initial preoperative refraction prior to the first surgery; not the current refraction. Pre-Operative Spherical Equivalent +2.00D to -3.00D -3.00D to -6.00D -6.00D or greater FML 0.1% Duration Guideline Qid x 1 month then stop Qid x 1 month Tid x 1 month Bid x 1 month Qd x 1 month then stop Qid x 2 months Tid x 1 month Bid x 1 month Bid/qd alternating x 1 month Qd x 1 month Qd every 2nd day x 1 month Then 1 gtt 2 times per week x 1 month Guidelines in altering FML 1% taper regimens: 1) If the patient has corneal haze, increase the dose and advise UV protection. 2) If the patient shows myopic regression, increase dose and/or maintain current dosage for longer. 3) If the patient has a hyperopic response, consider decreasing the FML dosage faster Examples of deviation from protocol: 1. Patient s post op Rx is -0.75D and is currently on FML bid, consider increasing to qid. 2. Patient s post op Rx is +1.00D and is currently on FML qid, consider decreasing to bid. 3. Patient s post op Rx is +1.00D and has significant corneal haze: treat aggressively with FML medications i.e. qid (the need to treat the haze is priority over the hyperopia). NOTE: Patients who show consistent regression and are more than 6 months post surgery, are unlikely to respond to an increase in FML and should be monitored for stability in consideration of enhancement. NOTE: All patients require monthly tonometry measurements while taking FML. gimbel.com 12 Printed in Canada 2013

13 Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 Corneal Surgery Post Operative Presentation and Activity Restrictions The following is a summary of potential symptoms and findings associated with each surgery. For the normal findings, an expected timeline for the finding to subside is provided. (H= hours, D= days, W=Weeks, M= Months) Type of Surgery Normal (Time to Subside) Not Normal Activity Restrictions IntraLASIK PRK/PTK * AK does not have the same discomfort elements as PRK and PTK VA 20/15 to 20/50 (may take 3-5 days to start improving) Foreign Body Sensation (48 H) Tearing/Photophobia (72H) Dry Eyes (up to 6M) Sub-conjunctival hemorages (2-3W) Ghosting/Halos/Glare (2-3M) Less contrast sensitivity (improves up to 6M but usually reaches 98% of original contrast) Epithelial edema (2-4W) VA 20/30 to 20/400 (up to 1W) Mild to severe pain (48H) Foreign body sensation (3-5D) Tearing, Photophobia (3-5D) Lid edema (3-5D) Ghost images (2-4W) Dry eyes (up to 3 M) Halo/Glare (2-3M) Drop in VA/diplopia (occurs at day 3-5 and is a result of fusion line formation)(72h) Less contrast sensitivity (improves up to 6M but usually reaches 98% of original contrast) Descemet s Folds (72H) Epithelial Defect (3-5D) Presence of Contact Lens (remove after re-epithelialization) Pus-like discharge Dislocated/wrinkled flap Unusually high pain Interface cloudiness Epithelial Defect Infiltrate Epithelial cells under flap Foreign body/debris under flap Diffuse Lamellar Keratitis Pus-like discharge Infiltrate/infection Anterior chamber cells Non-healing epithelial defect (beyond 5-7 days) Raised IOP (check after 3W) Corneal haze No pets in the bed for 2 nights after surgery No eye make-up for 7 days No swimming, hot tub, water sports for 21 days No Dusty/smoky environments for 21 days No eye rubbing for 6 weeks UV protection for 6 months Safety glasses during appropriate activities No heavy lifting x 3-4 days No upside-down positions i.e. yoga x 3-4 days Last Revised April gimbel.com

14 Corneal Refractive Surgery Complications This list contains the most likely observed complications. If you have any questions please contact us. Complication IntraLASIK PRK/PTK/ AK Description Treatment Dry Eyes X X Common after surgery and usually improves over time although can be permanent. If severe diffuse SPK noted, consider preservative toxicity. Inflammation X X May present as whitish distinct or diffuse infiltrates sometimes in a perilimbal arcuate pattern. Risk of corneal melt in rare cases. Look for corneal thinning. May be associated with systemic autoimmune conditions. Halos/ Starbursts X X Usually diminish over a few months but can be permanent and affect night driving. Patients with large pre-op pupil size should be advised of this potential risk. Epithelial Ingrowth X Migration and proliferation of epithelial cells under the flap. More common after relifting of a flap i.e. enhancements. May cause blurry vision, FBS, dryness, tearing. Infection X X Rare but possible. Ulcers, epithelial defects, haze, decrease in vision, pus-like discharge, red eye. Corneal Haze X X With IntraLASIK can have patchy areas of haze that are not clinically significant. With PRK it appears like superficial white grainy subepithelial cells that don t stain. It typically presents within 1 month and peaks around 2-3 months before subsiding. Ectasia X X Corneal instability resulting in refractive error, vision decline with visual distortion. Usually requires topography to diagnose. Flap Disturbances X Mild wrinkles, shifting of flap, striaie formation. May or may not be visually significant. Traditional Dry Eye Therapy modalities Refer to GEC for assessment. Prompt and aggressive treatment is needed. Usually subsides but can use yellow tinted glasses, or Alphagan gtts prn Monitor, if migrating more than 1 mm consider surgical intervention. Contact GEC for guidance in treatment For PRK: Advise UV protection, treat with steroids. In rare cases, PTK may be considered. Refer to GEC for assessment if vision affected. Refer to GEC for assessment. More on next page gimbel.com 14 Printed in Canada 2013

15 Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 Corneal Refractive Surgery Complications and Treatment (con t) Complication Intra LASIK PRK/PTK/ AK Description Treatment Epithelial Erosion X X May result in loose epithelium, rough edges or defects especially along flap margin in IntraLASIK, or ablation zone in PRK. Foreign body sensation, pain especially when opening eyes in the morning, decrease in vision. Increases risk of DLK and epithelial ingrowth in IntraLASIK patients. May subside as eye heals further. Copious nonpreserved lubrication. Some cases may require antibiotics and/ or bandage contact lens. Rarely, PTK may be considered. Diffuse Lamellar Keratitis (Sands of Sahara) X Rapid onset, non-infectious white blood cells reaction in the interface (looks like fine white grainy cells). May have pain, blurry vision, FBS, photophobia and can rapidly progress if not aggressively treated. In early stages may be asymptomatic and limited to the periphery of the flap, and one needs to rely on clinical diagnosis. More severe cases can involve the central cornea, and present with sand-dune-like cell accumulation, hazy flap, edema and striaie. Usually occurs within 1-3 days post-operatively but can also present later in cases of trauma. Prompt and aggressive treatment is needed. Please contact GEC immediately so the surgeon can be involved in treatment as this has the potential to have permanent vision effects. Refractive Error X X May be due to regression (mild keratometry changes from either epithelial fill-in or prolific epithelial growth resulting in refractive error). May settle/resolve over time. May also be influenced by dry eyes, therefore dry eye therapy is recommended for all patients with post-operative refractive error. Consider enhancement after 3 months of stable vision. Coverage is 18 months. Minimum refractive error is >0.50D. May enhance only one eye at a time. If deemed unsafe, the surgeon may advise against further surgery. Last Revised April gimbel.com

16 Phakic IOL Refractive Surgery Descriptions Phakic IOLs refer to synthetic implants that are inserted into the eye without removing the natural crystalline lens. They are considered a premium option as they provide superior quality of optics compared to corneal refractive surgery in all but relatively small refractive errors. They are removable, preserve remaining natural accommodation, and pose less retinal risk compared to lensectomy surgeries i.e. Refractive Lens Exchange. Please be aware that the need for special testing, calculations, and lens implant ordering times necessitates a processing time of 1-3 months from the date of the initial consultation to the actual surgery date. Gimbel Eye Centre currently performs two types of Phakic IOL surgeries: Implantable Collamer Lenses (ICL) Performed at Gimbel Eye Centre since 1997, this implant sits in the posterior chamber, supported by the sulcus and aqueous humour pressure. Prior to the day of surgery, a prophylactic peripheral iridotomy will be performed (usually 2 iridotomies between the 10 and 2 o clock position in the eye). This is done to ensure adequate aqueous flow. Occasionally, a single Surgical Iridectomy will be chosen instead, if the patient s irises are very darkly pigmented. The surgery takes about 15 minutes per eye, involves less than a 3 mm self-sealing clear corneal incision, and usually no stitches or needles are required. After the incision is made, and the anterior chamber is filled with a viscoelastic material, the implant is placed initially in the anterior chamber. Then the plate haptics are manipulated to go behind the iris, so that the implant vaults over the natural crystalline lens. If a Toric Implant is inserted, the surgeon manipulates the implant to the desired orientation. The viscoelastic material is flushed from the eye and care is taken to ensure the wound is secure. These implants are not visible to the naked eye. Angle Supported Phakic IOL (Cachet) Performed at Gimbel Eye Centre since 2010, this surgery differs from ICL in that the lens (or implant) is placed in the anterior chamber. It is supported by its flexible haptics nestled in the anterior chamber angle, similar to a shower curtain rod. The surgery takes about 15 minutes per eye, involves less than a 3 mm self-sealing clear corneal incision, and usually no stitches or needles are required. After the incision is made, and the anterior chamber is filled with a viscoelastic material, the implant is placed in front of the iris in the anterior chamber. The flexible haptics are manipulated into position. The viscoelastic material is flushed from the eye and care is taken to ensure the wound is secure. These implants can be cosmetically visible at close range with proper lighting, much like the edge of a contact lens. gimbel.com 16 Printed in Canada 2013

17 Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 Phakic IOL Surgery Patient Selection Eligibility Criteria for Phakic IOL Surgery Type of Surgery Refractive Range Healing Time/Time off Work Other Considerations ICL -2.75D to D +2.00D to D cyl up to -5.00D (myopic torics only) 3 days healing 1 week off work (for numerous appointments) Minimum AC depth 2.6/2.75 mm. Younger patients need more generous AC depth Corneal diameter mm Bioptics can be considered Cachet -6.00D to D 3 days healing 3-4 days off work (for numerous appointments) Minimum AC depth plus pachymetry = 3.2 mm Must meet minimum age adjusted endothelial cell count Mesopic pupil size <7.00D Corneal diameter mm Bioptics can be considered * The patient should be at least 18 years of age, not pregnant or nursing, with at least 12 months of stable refractions (within +/-0.50D). Contraindications for Phakic IOL Surgery Category Condition Comments Ocular Pathology Glaucoma May impede aqueous flow Pigment Dispersion Syndrome Recurrent Uveitis Binocular Dysfunction Amblyopia Other i.e. macular degeneration, retinal holes/tears Implant may interact with weakened iris layer, worsening the condition Implant may exacerbate the condition If prism required in glasses and/or pt experiences diplopia/headaches with contact lenses, then there may be a risk of decompensation after surgery Pt must understand the risks/implications of doing surgery on an amblyopic system Priority will be given to the pathology first. Consider potential vision loss. Systemic Pathology Diabetes Must not have any retinopathy, and blood sugar levels should be controlled. Consider infection risk. Immuno-compromised Patients: HIV, AIDS, Hepatitis Prefer that the patient is on HART therapy and the virus is not detectable in the blood. Consider infection risk. For Hep B or C, consider risk of transmission. Last Revised April gimbel.com

18 Phakic IOL Postoperative Care Postoperative Medication and Follow Up Regimen Type of Phakic IOL Surgery Medications/Treatment Protocol Follow Up Schedule ICL Prednisolone 1.0%: qid starting day of surgery until 1 week post op bid x 2 weeks Vigamox 0.5%: qid starting 1 day pre-op until 1 week post op Day 1, Week 2, Month 2, Month 6, Month 12, then yearly eye examinations Emergency Medications: Cyclogel 1.0% bid x 3 days Phenylephrine 10% bid x 3 days ( to be taken if symptoms of brow ache, pt to first contact their follow up Doctor) Artificial tears: q1h for 1-2 days then prn Cachet Prednisolone 1.0%: qid starting day of surgery until 1 week post op bid x 2 weeks Vigamox 0.5%: qid starting 1 day pre-op until 1 week post op Artificial tears: q1h for 1-2 days then prn Day 1, Week 2, Month 2, Month 6, Month 12, then yearly eye examinations * Pt is required to return to GEC every 6 months for Specular Microscopy for an indefinite period of time. The patient will remain with their Primary Eyecare Provider for all routine eye care. The fee for each Specular Microscopy visit is $75. * Please do once yearly gonioscopy testing to monitor for angle synechiaie * Additional visits should be performed as deemed clinically necessary. The post operative co-management fee includes the first 12 months of follow up, not including the yearly eye examination. gimbel.com 18 Printed in Canada 2013

19 Surgery Co-Management Guide LEADERS IN CORRECTIVE EYE SURGERY SINCE 1964 Phakic IOL Post Operative Presentation and Activity Restrictions The following is a summary of potential symptoms and findings associated with each surgery. For the normal findings, an expected timeline for the finding to subside is provided. (H= hours, D= days, W=Weeks, M= Months) Type of Surgery Normal (Time to Subside) Not Normal Activity Restrictions ICL VA 20/15 to 20/50 (accommodation may be affected by pupil dilation) Foreign Body Sensation (48 H) Tearing/Photophobia (48H) Dry Eyes (up to 2M) Ghosting/Halos/Glare (may take a while for pupil to return to normal size )(6M) Edema at the incision side (1W) Descemet s Folds (72H) Pupil Dilation (48H) Vault 2-4+ (see next page) Orientation should be on target immediately Mild AC reaction (1-2+ cells, 1+flare) Cachet VA 20/15 to 20/50 Foreign Body Sensation (48 H) Tearing/Photophobia (48H) Dry Eyes (up to 2M) Ghosting/Halos/Glare 6M) Edema at the incision site (1W) Descemet s Folds (72H) Pus-like discharge Wound gaping/leak Unusually high pain Epithelial Defect Elevated IOP High Vault (see next page) Low to No Vault Shallow Angle Iris to Corneal touch Iris Transillumination Non resolving anterior chamber reaction Iridotomy not patent Progressively excessive deposits on the IOL Anterior subcapsular lens changes ICL is rotated (see next page) Retinal Detachment Pus-like discharge Wound gaping/leak Unusually high pain Significant corneal haze Non-resolving Descemet s folds Elevated IOP Progressive pigment on IOL Implant sits close to the cornea Pupil irregular Haptics not located in angle Anterior Subcapsular lens changes Iris Transillumination Non resolving AC reaction No pets in the bed for 2 nights after surgery No eye make-up for 7 days No swimming, hot tub, water sports for 14 days No Dusty/smoky environments for 14 days No vigorous eye rubbing Safety glasses during appropriate activities Last Revised April gimbel.com

20 Phakic IOL Postoperative Evaluation Considerations The Phakic IOLs have special considerations during the follow up care. If you have any questions please contact us. Type of Surgery Special Consideration Description/Evaluation Interpretation ICL Vaulting The subjective assessment of how many central IOL thicknesses could be placed in the space between the natural crystalline lens and the implant. This may be influenced by implant length, thickness, position in the sulcus, trapped viscoelastic fluid behind the implant, and PI patency. Example: 2 IOL thicknesses= 2+ vault Vault less than 1+ poses risk of cataract formation Vault more than 4+ poses risk of pupil block In both situations, GEC should be notified. Orientation The subjective assessment of the location of the Toric engraving on the implant haptic, in relation to a 180 degree scale. Must be done dilated to see the marking. Example: 030 degrees * Note this does NOT equal refractive error axis If orientation does not match intended orientation, refractive error will be impacted Consider improper implant rotation if pt presents with a significant hyperopic astigmatic error Example: x 010 Cachet Vaulting Given the very flexible haptics, the implant length is much more forgiving in these implants. In general one would like to see a small vault over the iris so as not to rub the iris, but not too high as to risk endothelial damage. A very high vault may risk endothelial cell damage over time Orientation Although Cachet implants are not available in astigmatic correction, and therefore orientation does not impact refractive error, practitioners are still encouraged to document the physical orientation of the implant in relation to a 180 degree scale. Rotation would indicate too loose a fit or eye rubbing Implant rotation would risk damage to the trabecular meshwork and/or endothelium. gimbel.com 20 Printed in Canada 2013

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