Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results

NCT03437434 — Unknown, 40 participants, DAVID HAUSER

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

Registry	NCT03437434
Status	Unknown
Study type	Observational
Enrollment	40 (Estimated)
Sponsor	DAVID HAUSER (Other)
Conditions	Aphakia, Acquired
Interventions	Visual Acuity (Other)
Dates	start 2017-04-24, primary completion 2018-03-24 (estimated), completion 2018-04-24 (estimated), first posted 2018-02-19, last updated 2018-02-19
Locations	1 site in Israel

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
BunnyLens and Gore-Tex suture		Other: Visual Acuity	All patients Underwent 4 point PC-IOL scleral fixation with Gore-Tex sutures

Visual Acuity (Other), also known as Refraction, Biomicroscopy: Ocular Examination

+Outcome measures

Primary outcomes

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 outcomes

Slit Lamp Biomicroscopy [Up to 24 months from surgery.]: Slit lamp examination of the anterior and posterior segments.

+Eligibility

Sex: All, ages: 15 Years to 99 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Barzilai University Medical Center	Ashkelon	Israel	Recruiting

+Investigators

David Hauser, MD, Principal investigator, Barzilai University Medical Center