Clinical Trials Directory

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

TypeNameDescription
PROCEDUREIOL implantation surgery for aphkic eyeAphakic 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.