Epiretinal Proliferation in Eyes With Full Thickness Macular Hole

• Sponsor: Kyorin University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03376776
• Collaborator: (none)
• Enrollment: 390
• Location: 1
• Actual Duration (Months): 57
• Patients Per Site Per Month: 6.8

Study Details

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	Phase
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: Mar 1, 2013
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	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 [6 months]

Secondary Outcome Measures

1. Visual improvement [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Eyes with macular hole

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Makoto Inoue	Mitaka-shi	Tokyo	Japan	181-8611

Sponsors and Collaborators

• Kyorin University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Makoto Inoue, Professor of Ophthalmology, Kyorin University
• ClinicalTrials.gov Identifier: NCT03376776
• Other Study ID Numbers: Kyorineye024
• First Posted: Dec 18, 2017
• Last Update Posted: Dec 18, 2017
• Last Verified: Dec 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Makoto Inoue, Professor of Ophthalmology, Kyorin University: idiopathic macular hole
• Additional relevant MeSH terms: Retinal Perforations

Study Results

No Results Posted as of Dec 18, 2017