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This is a prospective comparative non-randomized cohort study to understand the long-term vision outcomes, safety, and stability of anterior chamber intraocular lenses (AC IOLs) vs. scleral-fixated intraocular lenses (SF IOLs).
On the pre-operative visit, specular microscopy, biometry, applanation tonometry and ocular coherence tomography (OCT) will be performed. The patient will then undergo treatment as per surgeon's discussion/ decision with the patient for implantation of an AC-IOL or SF-IOL. Participation in the study will not impact the management plan in any way. Specular microscopy will be performed wit the CellChek XL (Konan Medical, Irvine, CA). Biometry will be performed with the IOLMASTER (Carl Ziess Meditec, Jena, Germany), and anterior segment and macular OCT will be performed with the Cirrus-HD OCT (Carl Zeiss Metidec, Jena, Germany). EC count, OCT (macula and anterior segment) and specular microscopy will be performed at baseline, week 1, month 1, month 6, 12 and 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraocular lens implantation: AC IOL | Patients who are scheduled to undergo AC IOL (anterior chamber intraocular lens) implantation for any of the following indications:
|
| |
| Intraocular lens implantation: SF IOL | Patients who are scheduled to undergo SF IOL (scleral fixated intraocular lens) implantation for any of the following indications:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular lens implantation | Device | Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial cell loss | Change in endothelial cell count from baseline compared to 24 months post-operatively. | Pre-operative (baseline) and 24 weeks post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected distance visual acuity (CDVA) | CDVA will be measured using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart | Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary adverse events (SAE's) | Occurrence of cystoid macular edema (CME), retinal detachment, UGH syndrome, vitreous or choroidal hemorrhage, lens subluxation/ dislocation, glaucoma, uveitis, etc. | Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively. |
Inclusion Criteria:
Exclusion Criteria:
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All patients who are planned to undergo surgical implantation of an anterior chamber intraocular lens or a scleral-fixated IOL who present to the study investigators as part of the vitreoretinal surgery team at Sunnybrook Hospital or the Toronto Western Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cindy Rutz | Contact | 416 480 5091 | cindy.rutz@sunnybrook.ca | |
| Faryal Maniyali | Contact | 416 480 6100 | 2870 | faryal.maniyali@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Peter Kertes, MD | Sunnybrook Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Hospital | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25448990 | Background | Chan TC, Lam JK, Jhanji V, Li EY. Comparison of outcomes of primary anterior chamber versus secondary scleral-fixated intraocular lens implantation in complicated cataract surgeries. Am J Ophthalmol. 2015 Feb;159(2):221-6.e2. doi: 10.1016/j.ajo.2014.10.016. Epub 2014 Oct 22. | |
| 30298105 | Background | Krysik K, Dobrowolski D, Wroblewska-Czajka E, Lyssek-Boron A, Wylegala E. Comparison of the Techniques of Secondary Intraocular Lens Implantation after Penetrating Keratoplasty. J Ophthalmol. 2018 Sep 12;2018:3271017. doi: 10.1155/2018/3271017. eCollection 2018. |
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| ID | Term |
|---|---|
| D055954 | Corneal Endothelial Cell Loss |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D005132 | Eye Manifestations |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D019654 | Lens Implantation, Intraocular |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| 17070590 | Background | Kwong YY, Yuen HK, Lam RF, Lee VY, Rao SK, Lam DS. Comparison of outcomes of primary scleral-fixated versus primary anterior chamber intraocular lens implantation in complicated cataract surgeries. Ophthalmology. 2007 Jan;114(1):80-5. doi: 10.1016/j.ophtha.2005.11.024. Epub 2006 Oct 27. |
| 29219957 | Background | Negretti GS, Lai M, Petrou P, Walker R, Charteris D. Anterior chamber lens implantation in vitrectomised eyes. Eye (Lond). 2018 Mar;32(3):597-601. doi: 10.1038/eye.2017.261. Epub 2017 Dec 8. |
| 28457613 | Background | Yamane S, Sato S, Maruyama-Inoue M, Kadonosono K. Flanged Intrascleral Intraocular Lens Fixation with Double-Needle Technique. Ophthalmology. 2017 Aug;124(8):1136-1142. doi: 10.1016/j.ophtha.2017.03.036. Epub 2017 Apr 27. |
| 28410720 | Background | Brunin G, Sajjad A, Kim EJ, Montes de Oca I, Weikert MP, Wang L, Koch DD, Al-Mohtaseb Z. Secondary intraocular lens implantation: Complication rates, visual acuity, and refractive outcomes. J Cataract Refract Surg. 2017 Mar;43(3):369-376. doi: 10.1016/j.jcrs.2016.12.024. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |