Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results

Gore-Tex Suture and BunnyLens Scleral Fixation - Historical Retrospective Trial

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.

Study Overview

• Status: Unknown
• Conditions: Aphakia, Acquired
• Intervention / Treatment: Other: Visual Acuity

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Israel
  • Ashkelon, Israel, 7830604
    • Recruiting
    • Barzilai University Medical Center
    • Contact: Ornit Cohen, M.Med.Sc; Phone Number: 972 8 6746146; Email: ornitc@bmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 99 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are capable of inform consent and are eligible according to the inclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BunnyLens and Gore-Tex suture; All patients Underwent 4 point PC-IOL scleral fixation with Gore-Tex sutures	Other: Visual Acuity; Ocular Examination; Other Names: Refraction; Biomicroscopy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Biomicroscopy	Slit lamp examination of the anterior and posterior segments.	Up to 24 months from surgery.

Collaborators and Investigators

• Sponsor: DAVID HAUSER
• Investigators: Principal Investigator: David Hauser, MD, Barzilai University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2017
• Primary Completion (ANTICIPATED): March 24, 2018
• Study Completion (ANTICIPATED): April 24, 2018

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: February 11, 2018
• First Posted (ACTUAL): February 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 11, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Aphakia
• Other Study ID Numbers: 114-16-BRZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No