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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03244007
First Posted: August 9, 2017
Last Update Posted: August 9, 2017
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
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.

Condition Intervention
Macular Disease Procedure: Vitrectomy

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Recovery of microstructure [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Visual improvement [ Time Frame: 6 months ]

Enrollment: 30
Actual Study Start Date: December 12, 2015
Study Completion Date: June 11, 2017
Primary Completion Date: December 11, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  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
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The eyes with macular hole or lamellar macular hole
Criteria

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

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

  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): NCT03244007


Locations
Japan
Makoto Inoue
Mitaka-shi, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
Principal Investigator: Makoto Inoue, MD Korin Eye Center
  More Information

Responsible Party: Makoto Inoue, Professor of Ophthalmology, Kyorin University
ClinicalTrials.gov Identifier: NCT03244007     History of Changes
Other Study ID Numbers: Kyorineye023
First Submitted: August 5, 2017
First Posted: August 9, 2017
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Makoto Inoue, Kyorin University:
macular hole
lamellar macular hole