NCT02628262

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

December 6, 2015

Last Update Submit

December 8, 2015

Conditions

Macular Hole

Keywords

Macular hole

Outcome Measures

Primary Outcomes (1)

  • Visual acuity before and after surgery

    Vision

    Changes from baseline to 1,3, 6 months

Secondary Outcomes (1)

  • Fundus autofluorescence at the macula

    Changes from baseline up to 6 months

Interventions

Vitrectomy with internal limiting membrane removal and gas tamponadePROCEDURE

Vitrectomy with internal limiting membrane removal and gas tamponade

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • The patients were followed more than 6 months.

You may not qualify if:

  • The patient were followed less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makoto Inoue

Mitaka, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Retinal Perforations

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

December 6, 2015

First Posted

December 11, 2015

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)