Comparison of Scheimpflug Photos of the Crystalline Lens... | NCT00406263

Studies
Comparison of Scheimpflug Photos of the Crystalline Lens in Patients Who Have Undergone Vitrectomy Surgery and Controls

NCT00406263

Sponsor

Barnes Retina Institute

Status

Completed

Last Update Posted

Jul 27, 2016Estimated

Enrollment

49Actual

Phase

Not provided

Conditions

Nuclear Sclerotic Cataract

Interventions

Scheimpflug crystalline lens photographs

Countries

United States

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Nov 30, 2006

First Submission Date that Met QC Criteria

Nov 30, 2006

First Posted Date

Dec 4, 2006Estimated

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

Jul 25, 2016

Last Update Posted Date

Jul 27, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rhonda Weeks, Nancy Holekamp, MD, Principal Investigator, Barnes Retina InstitutePrincipal Investigator

Lead Sponsor

Barnes Retina InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Progression of nuclear sclerotic cataract after pars plana vitrectomy has been recognized for many years The mechanism for the rapid progression of nuclear sclerotic cataract remains unclear. The objective of this trial is to evaluate and compare the level and progression of cataract advancement in controls versus eyes that have undergone 20-gauge pars plana vitrectomy and 25-gauge pars plana vitrectomy.

Detailed Description

Approximately 105 patients will be recruited to obtain 35 control eyes that have not had pars plana vitrectomy and 35 eyes who will have undergone 20-gauge pars plana vitrectomy and 35 eyes will have undergone 25-gauge pars plana vitrectomy. Scheimpflug crystalline lens photographs will be taken for evaluation of level and progression of cataract development.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

49Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Scheimpflug crystalline lens photographs	Procedure	scheimpflug photographs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

phakic eyes of patients that are scheduled to undergo pars plana vitrectomy,
controls will be phakic eyes of patients that have not undergone andy kind of intraocular surgery,
age 18 and older

Exclusion Criteria:

any eye that is pseudophakic,
has had previous vitreoretinal surgery,
has had previous intravitreal injection,
previous intraocular inflammatory condition such as uveitis,
previous irradiation,
any patient with a history of ocular malignancy,
history of infectious intraocular condition

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients undergoing vitrectony surgery and controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nancy M Holekamp, MD	Barnes Retina Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barnes Retina Institute		St Louis	Missouri	63110	United States

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided