Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal

April 30, 2019 updated by: San Ni Chen, Changhua Christian Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

46

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wilcoxon Signed-Rank test
Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year
A statistical comparison of average of different time point
1 day, 1 week, 1 month, 3 months, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual acuity
Time Frame: 1 day, 1 week, 1 month, 3 months, 6 months and 1 year
visual acuity change in logMAR in different time point
1 day, 1 week, 1 month, 3 months, 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhua Christian Hospital

Investigators

  • Principal Investigator: San-Ni Chen, MD, Changhua Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Macular Pucker

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe