Inner Nuclear Macular Microcyst is a Risk Factor for Macu... | NCT03934190

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2014Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Mar 31, 2019Actual

First Submitted Date

Apr 29, 2019

First Submission Date that Met QC Criteria

Apr 29, 2019

First Posted Date

May 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2019

Last Update Posted Date

May 2, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

San Ni Chen, Director of Department of Ophthalmology, Changhua Christian HospitalPrincipal Investigator

Lead Sponsor

Changhua Christian HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Name	Affiliation	Role
San-Ni Chen, MD	Changhua Christian Hospital	Principal Investigator

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D019773	Epiretinal Membrane
D008269	Macular Edema

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D008268	Macular Degeneration
D012162	Retinal Degeneration