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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

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ClinicalTrials.gov Identifier: NCT03934190
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
San Ni Chen, Changhua Christian Hospital

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

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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 1, 2014
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 31, 2019



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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934190


Sponsors and Collaborators
Changhua Christian Hospital
Investigators
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Principal Investigator: San-Ni Chen, MD Changhua Christian Hospital
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Responsible Party: San Ni Chen, Director of Department of Ophthalmology, Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT03934190    
Other Study ID Numbers: 141012
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by San Ni Chen, Changhua Christian Hospital:
macular edema
pseudophakic cystoid macular edema
macular pucker
internal limiting membrane peeling
pars plana vitrectomy
Additional relevant MeSH terms:
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Epiretinal Membrane
Retinal Diseases
Eye Diseases