Corneal Changes After Retinal Surgery | NCT01446367

Studies
Corneal Changes After Retinal Surgery

NCT01446367

Sponsor

Universidade Federal do Paraná

Status

Completed

Last Update Posted

Oct 5, 2011Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Rhegmatogenous Retinal Detachment

Interventions

Not provided

Countries

Not provided

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

Oct 2011

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

Feb 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Oct 3, 2011

First Submission Date that Met QC Criteria

Oct 4, 2011

First Posted Date

Oct 5, 2011Estimated

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

Oct 4, 2011

Last Update Posted Date

Oct 5, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexandre Grandinetti, Principal Investigator, Universidade Federal do ParanáPrincipal Investigator

Lead Sponsor

Universidade Federal do ParanáOTHER

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

The purpose of this study is to evaluate the corneal changes after performing 20 gauge vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal detachment.

Detailed Description

Patients submitted to 20-gauge vitrectomy associated with scleral buckling were evaluated with corneal topography before surgery and in the 7,30 and 90 days after surgery to asses corneal curvature changes.

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

25Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with rhegmatogenous retinal detachments

Exclusion Criteria:

Previous eye surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with rhegmatogenous retinal detachments

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10442898	Background	Weinberger D, Lichter H, Loya N, Axer-Siegel R, Muzmacher L, Gabbay U, Yassur Y. Corneal topographic changes after retinal and vitreous surgery. Ophthalmology. 1999 Aug;106(8):1521-4. doi: 10.1016/S0161-6420(99)90447-5.