Viewing Study NCT03437434


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Study NCT ID: NCT03437434
Status: UNKNOWN
Last Update Posted: 2018-02-19
First Post: 2018-01-21
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results
Sponsor: DAVID HAUSER
Organization:

Study Overview

Official Title: Gore-Tex Suture and BunnyLens Scleral Fixation - Historical Retrospective Trial
Status: UNKNOWN
Status Verified Date: 2018-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: