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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