Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03934190 Completed May 1, 2019 May 2, 2019

study description
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.

Condition or Disease: Macular Pucker
Macular Cyst
Intervention/treatment:
Phase: N/A
Detailed Description

N/A


study design
Study Type: Observational
Estimated Enrollment : 46 participants
Intervention Model : N/A
Masking: N/A
Primary Purpose: N/A
Official Title: Inner Nuclear Macular Microcyst is a Risk Factor for Macular Cystoid Changes After Phacoemulsification in Eyes With Previous Vitrectomy and Macular Pucker Removal
Actual Study Start Date: October 2014
Actual Primary Completion Date: January 2019
Actual Study Completion Date: March 2019
outcome measures
Primary Outcome Measures: 1. 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
Secondary Outcome Measures: 1. 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

Eligibility Criteria
Ages Eligible for Study: 50 to 80 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

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.


Contacts and Locations
Contacts
Locations
Sponsors and Collaborators
Changhua Christian Hospital
Investigator
Principal Investigator : San-Ni Chen, MD Changhua Christian Hospital
More Information
Responsible Party : Changhua Christian Hospital
ClinicalTrials.gov Identifier : NCT03934190     
Other Study ID Numbers : 141012
First Posted : May 1, 2019
Last Update Posted : May 2, 2019
Last Verified : April 2019
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Changhua Christian Hospital: macular edema
pseudophakic cystoid macular edema
macular pucker
internal limiting membrane peeling
pars plana vitrectomy
Additional relevant MeSH terms :
Epiretinal Membrane