Optical Coherence Tomography-based Positioning for Macular Hole Surgery

January 6, 2016 updated by: Makoto Inoue, Kyorin University

Duration of Prone Positioning After Macular Hole Surgery Determined by Swept Source Optical Coherence Tomography

The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. The macular hole closure and visual outcome were compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. All eyes were treated by pars plana vitrectomy, internal limiting membrane peeling, and gas tamponade. MH closure was defined as a connection of the edges of the sensory retina in the SS-OCT images.The macular hole closure and visual outcome were compared.

Study Type

Observational

Enrollment (Actual)

125

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

Non-Probability Sample

Study Population

The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images in 60 eyes was compared with the 69 eyes with same surgical procedure but the prone position determined by the surgeon's decision.

Description

Inclusion Criteria:

  • The patients were followed more than 2 months.

Exclusion Criteria:

  • Eye with axial length more than 26.0 mm

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
SS-OCTdetermined group
Eyes with macular hole surgery that the postoperative prone positioning was discontinued after detecting a closure by SS-OCT
Procedure: Macular hole surgery
Vitrectomy with internal limiting membrane removal and gas tamponade
Other Names:
  • Vitrectomy
Control group
Eyes with macular hole surgery that the halting of the prone position was determined by the surgeon
Procedure: Macular hole surgery
Vitrectomy with internal limiting membrane removal and gas tamponade
Other Names:
  • Vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular hole closure
Time Frame: Changes from baseline to 1, 2 months
Closure of macular hole
Changes from baseline to 1, 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity before and after surgery
Time Frame: Changes from baseline to 1, 2 months
Vision
Changes from baseline to 1, 2 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

May 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kyorineye0021

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

product manufactured in and exported from the U.S.

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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