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Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03437434
Enrollment
40
Registered
2018-02-19
Start date
2017-04-24
Completion date
2018-04-24
Last updated
2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphakia, Acquired

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.

Interventions

OTHERVisual Acuity

Ocular Examination

Sponsors

DAVID HAUSER
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Distance Visual AcuityUp 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 RefractionUp to 24 months from surgery.Refraction of the Ocular surfaces, measured in sphere, cylinder and axis.

Secondary

MeasureTime frameDescription
Slit Lamp BiomicroscopyUp to 24 months from surgery.Slit lamp examination of the anterior and posterior segments.

Countries

Israel

Contacts

Primary ContactDavid Hauser, MD
dehauser@gmail.com972-526700010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026