NCT03934190

Brief Summary

To evaluate the visual acuity, macular thickness, morphological changes after cataract surgery in eyes with previous vitrectomy for macular pucker. Associated risk factors were also investigated.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

4.3 years

First QC Date

April 29, 2019

Last Update Submit

April 30, 2019

Conditions

Macular PuckerMacular Cyst

Keywords

macular edemapseudophakic cystoid macular edemamacular puckerinternal limiting membrane peelingpars plana vitrectomy

Outcome Measures

Primary Outcomes (1)

  • Wilcoxon Signed-Rank test

    A statistical comparison of average of different time point

    1 day, 1 week, 1 month, 3 months, 6 months and 1 year

Secondary Outcomes (1)

  • visual acuity

    1 day, 1 week, 1 month, 3 months, 6 months and 1 year

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The general medical history of the patients was evaluated preoperatively. Comprehensive ophthalmological examinations including BCVA measurements and funduscopic examinations were performed at each visit. SD-OCT (Cirrus HD-OCT, Carl Zeiss Meditec, Dublin, CA) was used to measure the central macular thickness (CMT) and structural changes preoperatively, and at 1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively

You may qualify if:

  • Patients had macular pucker surgery before cataract surgery.
  • Follow up over 1 year.

You may not qualify if:

  • Patients had any surgical complications such as posterior capsule rupture, vitreous loss, prolapse through the wound or iris trauma
  • Patients had diabetes mellitus.
  • Patients had uveitis or other inflammatory eye disease.
  • Patients had history of retinal vein occlusion.
  • Patients had retinal detachment; or previous vitrectomy for a disease other than macular pucker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epiretinal MembraneMacular Edema

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesMacular DegenerationRetinal Degeneration

Study Officials

  • San-Ni Chen, MD

    Changhua Christian Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Ophthalmology

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 1, 2019

Study Start

October 1, 2014

Primary Completion

January 31, 2019

Study Completion

March 31, 2019

Last Updated

May 2, 2019

Record last verified: 2019-04