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Trial record 1 of 1 for:    Optical Coherence Tomography-based Positioning for Macular Hole Surgery
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Optical Coherence Tomography-based Positioning for Macular Hole Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02650739
First Posted: January 8, 2016
Last Update Posted: January 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Makoto Inoue, Kyorin University
  Purpose
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.

Condition Intervention
Macular Hole Surgery Procedure: Macular hole surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Duration of Prone Positioning After Macular Hole Surgery Determined by Swept Source Optical Coherence Tomography

Further study details as provided by Makoto Inoue, Kyorin University:

Primary Outcome Measures:
  • Macular hole closure [ Time Frame: Changes from baseline to 1, 2 months ]
    Closure of macular hole


Secondary Outcome Measures:
  • Visual acuity before and after surgery [ Time Frame: Changes from baseline to 1, 2 months ]
    Vision


Enrollment: 125
Study Start Date: May 2013
Study Completion Date: October 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Vitrectomy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • The patients were followed more than 2 months.

Exclusion Criteria:

  • Eye with axial length more than 26.0 mm
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650739


Sponsors and Collaborators
Kyorin University
Investigators
Principal Investigator: Makoto Inoue, MD Kyorin Eye Center
  More Information

Responsible Party: Makoto Inoue, Professor of Ophthalmology, Kyorin University
ClinicalTrials.gov Identifier: NCT02650739     History of Changes
Other Study ID Numbers: Kyorineye0021
First Submitted: January 6, 2016
First Posted: January 8, 2016
Last Update Posted: January 8, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases