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CompletedNCT06363448Updated May 2, 2025

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

An interventional study of Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia in Aphakia, Postcataract, sponsored by Sohag University. Completed at 2 sites in Egypt. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Aphakia, Postcataract

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03

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Corneal decompensation.
  • Jeopardized specular microscopy
  • retinal or choroidal detachment
  • retained Intraocular foreign body
  • uveitis, Scleromalacia
  • Reubeosis irides
  • previous anti-glaucoma surgery.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Yamani technique

    Yamani technique for aphakia

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

  • Active comparator
    Proline mesh for aphakia

    Proline mesh for aphakia

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

Interventions

  • ProcedureYamani 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.

05

What researchers measure

Primary outcomes

  1. Best corrected visual acuity (BCVA) in LogMAR

    Best corrected visual acuity (BCVA) in LogMAR

    Time frame: 6 months

06

Study locations

2 sites
  • Ophthalmology department, Sohag University
    Sohag, 82511, Egypt
  • Elshimaa A.Mateen
    Sohag, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06363448
Lead sponsor
Sohag University
Responsible party
Elshimaa A.Mateen (Assisstant Professor, Sohag University) — Principal investigator
First posted
Apr 12, 2024
Start date
Jan 1, 2024
Primary completion
Jun 30, 2024
Completion
Dec 30, 2024
Last update
May 2, 2025

Study contacts

Elshimaa A.Mateen, Doctor
principal investigator · Assistant professor of ophthalmology, Sohag University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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