NCT01266746

Brief Summary

The aim of this study is to determine the condition to detect the status of a macular hole by spectral domain optical coherence tomography (SD-OCT) in gas-filled eyes. The macular area is scanned by SD-OCT (OCT-4000, Carl Zeiss Meditec) in the patients who underwent vitreous surgery for macular hole to detect macular jole closure on postoperative days 1, 3, 7, and 30.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Shorter than P25 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, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

4 months

First QC Date

December 20, 2010

Last Update Submit

December 31, 2012

Conditions

Keywords

gas tamponade,macular hole,macular hole retinal detachment,optical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • macular hole closure detected by spectral domain optical coherence tomography

    The maular hole closure in eyes with intravitreal gas is detected by spectral domain optical coherence tomography

    Change from preoperative status up to postoperative day 30.

Secondary Outcomes (1)

  • preoperative and postoperative vision

    This was a prospective study conducted between April 2009 and August 2009. The vision is measured preoperatively and postoperative day 30.

Study Arms (3)

Macular hole

The patients of idiopathic macular hole enrolled in the study

Procedure: Vitreous surgery

Macular hole retinal detachment

The patients of macular hole retinal detachment enrolled in the study

Procedure: Vitreous surgery

Myopic traction maculopathy

The patients of macular hole with myopic traction maculopathy enrolled in the study

Procedure: Vitreous surgery

Interventions

Vitreous surgery is performed to treat the original disease not for the study.

Macular holeMacular hole retinal detachmentMyopic traction maculopathy

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who had a vitreous surgery for macular hole, macular hole retinal detachment, myopic traction maculopathy and examined spectral domain optical coherence tomography preoperatively and postoperatively.

You may qualify if:

  • the patients who had a vitreous surgery for macular hole, macular hole retinal detachment, macular hole with myopic traction maculopathy and examined spectral domain optical coherence tomography preoperatively and postoperatively.

You may not qualify if:

  • the patients who had vitreous surgery for other disease
  • the patients who did not have postoperative examination of spectral domain optical coherence tomography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Makoto INoue, MD

    Kyorin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 20, 2010

First Posted

December 24, 2010

Study Start

April 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations