Scleral Fixation of BunnyLens With GoreTex Suture- Initia... | NCT03437434

Studies
Scleral Fixation of BunnyLens With GoreTex Suture- Initial Results

NCT03437434

Sponsor

DAVID HAUSER

Status

Unknown status

Last Update Posted

Feb 19, 2018Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Aphakia, Acquired

Interventions

Visual Acuity

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2017Actual

Primary Completion Date

Mar 24, 2018Estimated

Completion Date

Apr 24, 2018Estimated

First Submitted Date

Jan 21, 2018

First Submission Date that Met QC Criteria

Feb 11, 2018

First Posted Date

Feb 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2018

Last Update Posted Date

Feb 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visual Acuity	Other	Ocular Examination	BunnyLens and Gore-Tex suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Slit Lamp Biomicroscopy	Slit lamp examination of the anterior and posterior segments.	Up to 24 months from surgery.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Hauser, MD	Contact	972-526700010		dehauser@gmail.com

Overall Officials

Name	Affiliation	Role
David Hauser, MD	Barzilai University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barzilai University Medical Center	Recruiting	Ashkelon		7830604	Israel

Condition Browse Module

MeSH Terms

ID	Term
D001035	Aphakia

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014792	Visual Acuity
D012029	Refraction, Ocular
D033401	Microscopy, Acoustic

Ancestor Terms

ID	Term
D014787	Vision Tests
D003941	Diagnostic Techniques, Ophthalmological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided