NCT01229657

Brief Summary

To evaluate the anatomic and visual outcomes in patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

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

March 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
Last Updated

October 28, 2010

Status Verified

October 1, 2010

Enrollment Period

2 months

First QC Date

October 27, 2010

Last Update Submit

October 27, 2010

Conditions

Macular Holes

Keywords

Reopening of macular hole;Visual acuity;Phacoemulsification cataract surgery;Vitrectomy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up

You may qualify if:

  • successful closure of a macular hole after initial vitreoretinal surgery
  • a follow-up of at least one year

You may not qualify if:

  • post-traumatic holes,
  • myopic macular holes,
  • macular holes associated with a rhegmatogenous retinal detachment,
  • eyes with silicone oil tamponade.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Shaochong Zhang, MD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2010

First Posted

October 28, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 28, 2010

Record last verified: 2010-10

Locations

CN(1)