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Completed

NCT Number: NCT06363448

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

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.

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elshimaa A.Mateen, Sohag, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Best corrected visual acuity (BCVA) in LogMAR

    Time frame: 6 months

    Best corrected visual acuity (BCVA) in LogMAR

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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