Comparison of Postoperative Aqueous Flare After 20G Versus 23G Pars Plana Vitrectomy (20Gvs23G)

May 29, 2015 updated by: Sascha Fauser, University of Cologne
To compare postoperative inflammation and breakdown of blood-retinal barrier as measured by a laser flare-cell meter in 20G versus 23G vitrectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Cologne, NRW, Germany, 50937
        • Center of Ophthalmology, University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

age > 18 years macular hole macular pucker willing to perform follow up written signed consent

Exclusion Criteria:

other relevant eye disease: retinal detachment, provect cataract, diabetic retinopathy, AMD, relevant glaucoma, pre-surgery except for cataract surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 20G
20G vitrectomy with scleral and conjunctival sutures for closure
Procedure: 20G Vitrectomy
Active Comparator: 23G
23G transconjunctival sutureless vitrectomy
Procedure: 23G vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alteration of aqueous flare between preoperative and 3-week-postoperative time point
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual acuity change
Time Frame: 3 weeks
3 weeks
Closure of Macular hole
Time Frame: 3 weeks
3 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 21, 2013

First Posted (Estimate)

October 25, 2013

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKK-13-247
  • 13-247 (Other Identifier: Ethics Committee University of Cologne)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Macular Pucker

Clinical Trials on 20G Vitrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe