Trials / Completed
CompletedNCT06933654
Iris Suture Fixation vs Iris Claw for Correction of Aphakia
Iris Suture Fixation vs Iris Claw for Aphakic Correction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Benha University · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate and compare the advantages and disadvantages of iris suture fixation versus iris claw of posterior chamber IOLs
Detailed description
The eyes were randomly divided into two groups, A and B. Group A included 25 eyes in which an iris claw lens was used; specifically, the Artisan aphakia intraocular lens (Ophtec BV, Groningen, The Netherlands), a PMMA IOL with an 8.5 mm length, 1.04 mm maximum height, and a 5.4 mm optical zone width. Group B also included 25 eyes, in which iris fixation of posterior chamber foldable IOLs was performed using a single-piece PMMA IOL. This IOL had a 6 mm optic, a total diameter of 12.75 mm, and featured one eyelet for suture fixation in each haptic. The A-constant used was 118.2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | IOL implantation surgery for aphkic eye | Aphakic eyes underwent secondary intraocular lens (IOL) implantation using one of two techniques. In Group A, an iris-claw IOL (Artisan aphakia IOL, Ophtec BV, The Netherlands) was implanted and fixated to the mid-peripheral iris via enclavation. In Group B, a posterior chamber foldable PMMA IOL was fixated to the iris using transscleral sutures passed through eyelets in the haptics. All procedures were performed under peribulbar anesthesia using standard aseptic technique, and postoperative management included topical antibiotics and corticosteroids. |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2024-11-30
- Completion
- 2024-12-01
- First posted
- 2025-04-18
- Last updated
- 2025-04-18
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT06933654. Inclusion in this directory is not an endorsement.