| Registry | NCT06363448 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 20 (Actual) |
| Sponsor | Sohag University (Other) |
| Conditions | Aphakia, Postcataract |
| Interventions | Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia (Procedure) |
| Dates | start 2024-01-01, primary completion 2024-06-30, completion 2024-12-30, first posted 2024-04-12, last updated 2025-05-02 |
| Locations | 2 sites in Egypt |
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All trials for Aphakia, Postcataract All trials of Yamani Technique versus Prolene 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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Yamani technique | Active comparator | Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia | Yamani technique for aphakia |
| Proline mesh for aphakia | Active comparator | Procedure: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia | Proline mesh for aphakia |
Sex: All, ages: 40 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Ophthalmology department, Sohag University | Sohag | Egypt | |
| Elshimaa A.Mateen | Sohag | Egypt |