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

NCT ID: NCT06363448

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-30

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

Conditions

Aphakia, Postcataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Yamani technique

Yamani technique for aphakia

Group Type: ACTIVE_COMPARATOR

Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia

Intervention Type: PROCEDURE

Patients were divided into two groups to undergo classic ab externo two-point scleral fixation or flanged haptics as described by Yamani or the 2\*2 proline mesh technique.

Proline mesh for aphakia

Proline mesh for aphakia

Group Type: ACTIVE_COMPARATOR

Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia

Intervention Type: PROCEDURE

Patients were divided into two groups to undergo classic ab externo two-point scleral fixation or flanged haptics as described by Yamani or the 2\*2 proline mesh technique.

Interventions

Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia

Patients were divided into two groups to undergo classic ab externo two-point scleral fixation or flanged haptics as described by Yamani or the 2\*2 proline mesh technique.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Elshimaa A.Mateen

Assisstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elshimaa A.Mateen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of ophthalmology, Sohag University

Locations

Ophthalmology department, Sohag University

Sohag, , Egypt

Elshimaa A.Mateen

Sohag, , Egypt

Countries

Egypt

Other Identifiers

Soh-Med-24-3-04PD

Identifier Type: -

Identifier Source: org_study_id