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Iris Suture Fixation vs Iris Claw for Correction of Aphakia

Iris Suture Fixation vs Iris Claw for Aphakic Correction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06933654
Acronym
IOLs
Enrollment
50
Registered
2025-04-18
Start date
2024-04-01
Completion date
2024-12-01
Last updated
2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphakic Eye

Keywords

Iris suture fixation , iris claw, aphakia

Brief 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.

Interventions

PROCEDUREIOL 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.

Sponsors

Al-Azhar University
CollaboratorOTHER
Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Best-corrected visual acuity (BCVA)at 6 months postoperativelyBCVA in logMAR , to evaluate and compare visual recovery between the iris-claw and iris suture-fixated IOL groups.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026