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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03934190
Other study ID # 141012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2014
Est. completion date March 31, 2019

Study information

Verified date April 2019
Source Changhua Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date March 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Changhua Christian Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 visual acuity visual acuity change in logMAR in different time point 1 day, 1 week, 1 month, 3 months, 6 months and 1 year
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