Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results

Aphakia, Acquired Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03437434
• Other study ID #: 114-16-BRZ
• Status: Recruiting
• Phase: N/A
• First received: January 21, 2018
• Last updated: February 11, 2018
• Start date: April 24, 2017
• Est. completion date: April 24, 2018

Study information

• Verified date: February 2018
• Source: Barzilai Medical Center
• Contact: David Hauser, MD
• Phone: 972-526700010
• Email: dehauser[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 24, 2018
• Est. primary completion date: March 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia
• Aphakia, Acquired

Intervention

Other:
• Visual Acuity
Ocular Examination

Locations

Country	Name	City	State
Israel	Barzilai University Medical Center	Ashkelon

Sponsors (1)

Lead Sponsor	Collaborator
DAVID HAUSER

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Ocular Refraction	Refraction of the Ocular surfaces, measured in sphere, cylinder and axis.	Up to 24 months from surgery.
Secondary	Slit Lamp Biomicroscopy	Slit lamp examination of the anterior and posterior segments.	Up to 24 months from surgery.