Epiretinal Proliferation in Eyes With Full Thickness Macular Hole

December 13, 2017 updated by: Makoto Inoue, Kyorin University
We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.

Study Type

Observational

Enrollment (Actual)

390

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

  • Japan
    • Tokyo
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Makoto Inoue

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

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The eyes with macular hole

Description

Inclusion Criteria:

  • Eyes with macular hole

Exclusion Criteria:

  • Eyes with retinal detachment, retinal vascular disease, glaucoma, proliferative diabetic retinopathy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eyes with epiretinal proliferation
The eyes with epiretinal proliferation around the macular hole detected with optical coherence tomography
Procedure: Vitrectomy
Eyes without epiretinal proliferation
The eyes without epiretinal proliferation around the macular hole detected with optical coherence tomography
Procedure: Vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recovery of foveal microstructure
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual improvement
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Kyorin University

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 (ACTUAL)

March 1, 2013

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

December 13, 2017

First Posted (ACTUAL)

December 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 18, 2017

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kyorineye024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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