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

• Sponsor: Kyorin University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03244007
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 18
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Macular Disease	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.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy
• Actual Study Start Date: Dec 12, 2015
• Actual Primary Completion Date: Dec 11, 2016
• Actual Study Completion Date: Jun 11, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Recovery of 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 or lamellar macular hole -

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

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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, Korin 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: NCT03244007
• Other Study ID Numbers: Kyorineye023
• First Posted: Aug 9, 2017
• Last Update Posted: Feb 20, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• 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, Professor of Ophthalmology, Kyorin University: macular hole; lamellar macular hole

Study Results

No Results Posted as of Feb 20, 2019