Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy

February 19, 2019 updated by: Makoto Inoue, Kyorin University
We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.

Study Type

Observational

Enrollment (Actual)

100

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

16 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The eyes with macular hole or lamellar macular hole

Description

Inclusion Criteria: Eyes with macular hole or lamellar macular hole -

Exclusion Criteria: Eyes with retinal detachment, retinal vascular disease, glaucoma

-

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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Eyes with residual fragment
The eyes with residual fragments detected with intraoperative optical coherence tomography
Procedure: Vitrectomy
Eyes without residual fragment
The eyes without residual fragments detected with intraoperative optical coherence tomography
Procedure: Vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recovery of 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

Investigators

  • Principal Investigator: Makoto Inoue, MD, Korin Eye Center

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)

December 12, 2015

Primary Completion (Actual)

December 11, 2016

Study Completion (Actual)

June 11, 2017

Study Registration Dates

First Submitted

August 5, 2017

First Submitted That Met QC Criteria

August 5, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 19, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Kyorineye023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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