Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia

Not Applicable

Completed

• Conditions: Aphakia, Postcataract
• Interventions: Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia

• Registration Number: NCT06363448
• Lead Sponsor: Sohag University

Brief Summary

The study aims to describe a new method of sulcus fixation of intraocular lenses (IOLs) using a prolene mesh and to compare its outcomes with Yamani technique.

Detailed Description

Properly positioned posterior chamber IOL (PCIOL) offers many advantages over an anterior chamber IOL (ACIOL). The potential advantages of PCIOLs over ACIOLs include a reduction in the number of optical aberrations (e.g. magnification, aniseikonia, lens edge glare, flutter), a decreased incidence of secondary glaucoma, and free movement of the pupil to control the amount of light entering the eye.

The risk for corneal decompensation, secondary glaucoma, and cystoid macular edema may be less with PCIOLs than with ACIOLs. In the absence of capsular support, many techniques have been described to secure the haptics to the sulcus region.

All described techniques focus on IOL haptics fixation to the scleral wall at two or more points. These techniques are not free of complications, including IOL tilt, misalignment, myopic shift, IOL suture rupture, and dislocation. In a previous study, Othman et al compared classic ab-externo two-point IOL fixation with a new technique of IOL scleral fixation based on fashioning trans-scleral, a double rectangular suture sulcus reconstruction (DRSSR) to support the IOL optic, thus providing a cushion to the IOL being positioned in the sulcus.

Aim of

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• patients aged 40 years
• aphakic patients (post-traumatic or after complicated cataract surgery without capsular support).

Exclusion Criteria

• Corneal decompensation.
• Jeopardized specular microscopy
• retinal or choroidal detachment
• retained Intraocular foreign body
• uveitis, Scleromalacia
• Reubeosis irides
• previous anti-glaucoma surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proline mesh for aphakia	Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia	Proline mesh for aphakia
Yamani technique	Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia	Yamani technique for aphakia

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity (BCVA) in LogMAR	6 months	Best corrected visual acuity (BCVA) in LogMAR

Trial Locations

Locations (2)

Elshimaa A.Mateen; 🇪🇬 Sohag, Egypt

Ophthalmology department, Sohag University; 🇪🇬 Sohag, Egypt