NCT03437434

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

January 21, 2018

Last Update Submit

February 11, 2018

Conditions

Aphakia, Acquired

Outcome Measures

Primary Outcomes (2)

  • 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.

  • Ocular Refraction

    Refraction of the Ocular surfaces, measured in sphere, cylinder and axis.

    Up to 24 months from surgery.

Secondary Outcomes (1)

  • Slit Lamp Biomicroscopy

    Up to 24 months from surgery.

Study Arms (1)

BunnyLens and Gore-Tex suture

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

Other: Visual Acuity

Interventions

Visual AcuityOTHER

Ocular Examination

Also known as: Refraction, Biomicroscopy
BunnyLens and Gore-Tex suture

Eligibility Criteria

Age15 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are capable of inform consent and are eligible according to the inclusion criteria.

You may qualify if:

  • patients that underwent secondary cataract surgery or IOL replacement and BunnyLens fixation with Gore-Tex sutures.

You may not qualify if:

  • Lack of Cooperation, death, severe physical or mental illness, patient's request to withdraw of the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barzilai University Medical Center

Ashkelon, 7830604, Israel

RECRUITING

MeSH Terms

Conditions

Aphakia

Interventions

Visual AcuityRefraction, OcularMicroscopy, Acoustic

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Vision TestsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisOcular Physiological PhenomenaOptical PhenomenaPhysical PhenomenaMicroscopyDiagnostic ImagingUltrasonographyInvestigative Techniques

Study Officials

  • David Hauser, MD

    Barzilai University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Hauser, MD

CONTACT

972-526700010dehauser@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Retina Ophthalmologist

Study Record Dates

First Submitted

January 21, 2018

First Posted

February 19, 2018

Study Start

April 24, 2017

Primary Completion

March 24, 2018

Study Completion

April 24, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

IL(1)