Fundus Autofluorescence After Macular Hole Surgery

• Sponsor: Makoto Inoue (Other)
• Overall Status: Completed
• CT.gov ID: NCT02628262
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Duration (Months): 30
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Funds autofluorescence (FAF) indicates hyper fluorescence at the macular hole in the patients with macular hole. Investigators investigate the association between FAF and visual acuity, recovery of foveal microstructure, and FAF in surgically closed macular holes.

Condition or Disease	Intervention/Treatment	Phase
Macular Hole	Procedure: Vitrectomy with internal limiting membrane removal and gas tamponade

Detailed Description

Ultrawide angle FAF images were taken in 27 eyes before and after macular hole surgery and compared with swept source optical coherence tomographic (SS-OCT) images.

Study Design

• Study Type: Observational
• Actual Enrollment: 27 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Fundus Autofluorescence Images in Gas-filled Eyes Immediately After Macular Hole Surgery
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Outcome Measures

Primary Outcome Measures

1. Visual acuity before and after surgery [Changes from baseline to 1,3, 6 months]

   Vision

Secondary Outcome Measures

1. Fundus autofluorescence at the macula [Changes from baseline up to 6 months]

   Fundus autofluorescence at the macula

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• The patients were followed more than 6 months.

Exclusion Criteria:

• The patient were followed less than 6 months.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Makoto Inoue

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Makoto Inoue, Professor of Ophthalmology, Kyorin University
• ClinicalTrials.gov Identifier: NCT02628262
• Other Study ID Numbers: Kyorineye020
• First Posted: Dec 11, 2015
• Last Update Posted: Dec 11, 2015
• Last Verified: Dec 1, 2015

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Makoto Inoue, Professor of Ophthalmology, Kyorin University: Macular hole
• Additional relevant MeSH terms: Retinal Perforations

Study Results

No Results Posted as of Dec 11, 2015