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Trial record 2 of 261682 for:    ALL

Epiretinal Proliferation in Eyes With Full Thickness Macular Hole

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.
ClinicalTrials.gov Identifier: NCT03376776
Recruitment Status : Completed
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Macular Disease Procedure: Vitrectomy

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 Design

Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Epiretinal Proliferation in Eyes With Full Thickness Macular Hole
Actual Study Start Date : March 2013
Primary Completion Date : January 2017
Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Recovery of foveal microstructure [ Time Frame: 6 months ]

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

Eligibility Criteria

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
Criteria

Inclusion Criteria:

  • Eyes with macular hole

Exclusion Criteria:

  • Eyes with retinal detachment, retinal vascular disease, glaucoma, proliferative diabetic retinopathy
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): NCT03376776


Locations
Japan
Makoto Inoue
Mitaka-shi, Tokyo, Japan, 181-8611
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: NCT03376776     History of Changes
Other Study ID Numbers: Kyorineye024
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

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:
idiopathic macular hole

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases