Iris Suture Fixation vs Iris Claw for Correction of Aphakia (IOLs)

Benha University

Status: Completed

Conditions: Aphakic Eye

Treatments: Procedure: IOL implantation surgery for aphkic eye

Study type: Interventional

Funder types: Other

Identifiers

NCT06933654

Benha University

aphakic correction

Details and patient eligibility

About

Evaluate and compare the advantages and disadvantages of iris suture fixation versus iris claw of posterior chamber IOLs

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Surgical aphakia with no capsular support, with CDVA 4/60 or better on Snellen chart including: Aphakic eyes after complicated cataract surgery, crystalline lens subluxation (Marfan syndrome, pseudoexofoliation syndrome or trauma), 2nd intervention in traumatized eyes, cases with sublaxated or dislocated IOLs.

Exclusion criteria

• Surgical aphakia with decompensated corneas, aphakic patients with posterior segment pathologies like cystoid macular edema, choroidal neovascular membrane, aphakic patients with insufficient iris tissue, and rubeosis iridis, aphakic patients with intractable glaucoma.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Group A (Iris claw IOL)

Active Comparator group

Description:

included 25 eyes in which the iris claw lens was used, the lens used in this study was the Artisan aphakia IOL (Ophtec BV, Groningen, The Netherlands) which is a PMMA IOL with an 8.5 mm length, 1.04-mm maximum height and 5.4-mm optical zone width.

Treatment:

Procedure: IOL implantation surgery for aphkic eye

Group B (Iris fixation IOL)

Active Comparator group

Description:

included 25 eyes were subjected to iris fixation of posterior chamber foldable IOLs. eyes in which a single piece PMMA IOL was implanted. The IOL is 6 mm optic, 12.75 mm overall diameter, and has one eyelet for suture fixation in each haptic. A constant was 118.2.

Treatment:

Procedure: IOL implantation surgery for aphkic eye