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

Recruiting

• Conditions: Corneal Endothelial Cell Loss; Secondary Intraocular Lens
• Interventions: Device: Intraocular lens implantation

• Registration Number: NCT04072978
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Study Start: 2019-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27
• Primary Completion: 2024-12-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. 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).
2. Patients on whom imaging (specular microscopy, biometry and OCT) can be performed without delaying their treatment (i.e. based on availability of operator).
3. Decision makers able to provide informed consent.

Exclusion Criteria

1. Inability to obtain adequate imaging, in the form of specular microscopy and OCT data at baseline.
2. Patients unable to attend follow-up visits.
3. Patients who have had a corneal transplant prior to secondary IOL implantation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intraocular lens implantation: AC IOL	Intraocular lens implantation	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
Intraocular lens implantation: SF IOL	Intraocular lens implantation	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

Primary Outcome Measures

Name	Time	Method
Endothelial cell loss	Pre-operative (baseline) and 24 weeks post-operatively.	Change in endothelial cell count from baseline compared to 24 months post-operatively.

Secondary Outcome Measures

Name	Time	Method
Corrected distance visual acuity (CDVA)	Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.	CDVA will be measured using a standardized Early Treatment Diabetic Retinopathy Study (ETDRS) chart

Trial Locations

Locations (1)

Sunnybrook Hospital; 🇨🇦 Toronto, Ontario, Canada