About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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 NCT03934190

Recruitment Status Completed

First Posted May 1, 2019

Last update posted 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
  • Actual Enrollment: 46 participants
  • Observational Model: Case-Only
  • Time Perspective: Retrospective
  • 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
  • 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
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

Investigators

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

More Information
  • Responsible Party: Changhua Christian Hospital
  • ClinicalTrials.gov Identifier: NCT03934190 History of Changes
  • Other Study ID Numbers: 141012
  • First Posted: May 1, 2019 Key Record Dates
  • 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