Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes

Conditions
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Corneal Endothelial Cell Loss, Secondary Intraocular Lens

Intervention / Treatment
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* Device: Intraocular lens implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are undergoing AC IOL or SF IOL implantation for any reason (including but not limited to aphakia, posterior capsular rupture, primary or secondary lens dislocation/ subluxation or IOL exchange). Patients on whom imaging (specular microscopy, biometry and OCT) can be performed without delaying their treatment (i.e. based on availability of operator). Decision makers able to provide informed consent. Exclusion Criteria: Inability to obtain adequate imaging, in the form of specular microscopy and OCT data at baseline. Patients unable to attend follow-up visits. Patients who have had a corneal transplant prior to secondary IOL implantation.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intraocular lens implantation: AC IOL<br>Patients who are scheduled to undergo AC IOL (anterior chamber intraocular lens) implantation for any of the following indications: primary or secondary aphakia primary or secondary lens subluxation or dislocation | Device: Intraocular lens implantation<br>* Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.<br>* Other names: IOL implantation;|
| Intraocular lens implantation: SF IOL<br>Patients who are scheduled to undergo SF IOL (scleral fixated intraocular lens) implantation for any of the following indications: primary or secondary aphakia primary or secondary lens subluxation or dislocation | Device: Intraocular lens implantation<br>* Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.<br>* Other names: IOL implantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |