Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results

• Conditions: Aphakia, Acquired
• Interventions: Other: Visual Acuity

• Registration Number: NCT03437434
• Lead Sponsor: DAVID HAUSER

Brief Summary

This study evaluates the Visual Acuity and refraction of patients post 4-point Scleral fixation of BunnyLens (Intra Ocular Lens- IOL) with GoreTex sutures. All patients underwent secondary IOL implantation or IOL exchange during 2014-2017.

Detailed Description

4 point scleral fixation of PC- IOL (Posterior Chamber-PC) BunnyLens with Gore-Tex sutures is a surgical technique for implanting IOL in patients with capsular support absence, due to trauma, abnormal anterior chamber, IOL dislocation, or ciliary zonule defect.

The 4 point fixation enables to align the PC- IOL with minimal vertical and horizontal deviation;The Gore-Tex sutures maintain stable scleral fixation with no suture erosion or breakage.

Study Timeline

• Study Start: 2017-04-24
• Study First Submitted: 2018-01-21
• Status Verified: 2018-02
• Study First Submitted QC: 2018-02-11
• Last Update Submitted: 2018-02-11
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19
• Primary Completion: 2018-03-24
• Study Completion: 2018-04-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients that underwent secondary cataract surgery or IOL replacement and BunnyLens fixation with Gore-Tex sutures.

Exclusion Criteria

• Lack of Cooperation, death, severe physical or mental illness, patient's request to withdraw of the clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BunnyLens and Gore-Tex suture	Visual Acuity	All patients Underwent 4 point PC-IOL scleral fixation with Gore-Tex sutures

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity	Up to 24 months from surgery.	Degree of Visual Acuity is measured in LogMar (-0.3 to1) and by Decimal Value (0.0-2.0)
Ocular Refraction	Up to 24 months from surgery.	Refraction of the Ocular surfaces, measured in sphere, cylinder and axis.

Secondary Outcome Measures

Name	Time	Method
Slit Lamp Biomicroscopy	Up to 24 months from surgery.	Slit lamp examination of the anterior and posterior segments.

Trial Locations

Locations (1)

Barzilai University Medical Center; 🇮🇱 Ashkelon, Israel