Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results

NCT ID: NCT03437434

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-24

Study Completion Date

2018-04-24

Brief Summary

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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

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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.

Conditions

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Aphakia, Acquired

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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BunnyLens and Gore-Tex suture

All patients Underwent 4 point PC-IOL scleral fixation with Gore-Tex sutures

Visual Acuity

Intervention Type OTHER

Ocular Examination

Interventions

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Visual Acuity

Ocular Examination

Intervention Type OTHER

Other Intervention Names

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Refraction Biomicroscopy

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DAVID HAUSER

OTHER

Sponsor Role lead

Responsible Party

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DAVID HAUSER

Retina Ophthalmologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Hauser, MD

Role: PRINCIPAL_INVESTIGATOR

Barzilai University Medical Center

Locations

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Barzilai University Medical Center

Ashkelon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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David Hauser, MD

Role: CONTACT

972-526700010

Facility Contacts

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Ornit Cohen, M.Med.Sc

Role: primary

972 8 6746146

Other Identifiers

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114-16-BRZ

Identifier Type: -

Identifier Source: org_study_id

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