Fundus Autofluorescence After Macular Hole Surgery

Macular Hole Clinical Trial

Official title:

Fundus Autofluorescence Images in Gas-filled Eyes Immediately After Macular Hole Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628262
• Other study ID #: Kyorineye020
• Status: Completed
• Phase: N/A
• First received: December 6, 2015
• Last updated: December 8, 2015
• Start date: April 2013
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• The patients were followed more than 6 months.

Exclusion Criteria:

• The patient were followed less than 6 months.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macular Hole
• Retinal Perforations

Intervention

Procedure:
• Vitrectomy with internal limiting membrane removal and gas tamponade
Vitrectomy with internal limiting membrane removal and gas tamponade

Locations

Country	Name	City	State
Japan	Makoto Inoue	Mitaka	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Makoto Inoue

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity before and after surgery	Vision	Changes from baseline to 1,3, 6 months	No
Secondary	Fundus autofluorescence at the macula	Fundus autofluorescence at the macula	Changes from baseline up to 6 months	No