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NCT01146964 Clinical Trial

Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

Cataract Clinical Trial

Official title:
Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01146964
Other study ID # 10003
Secondary ID
Status Completed
Phase N/A
First received June 2, 2010
Last updated January 2, 2014
Start date May 2010
Est. completion date June 2011

Study information
Verified date January 2014
Source Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Age related cataract patients

- Cataract density grade II-III according to the Emery-Little system classification system

Exclusion Criteria:

- Legal guardian(s) is/are not present for permission

- Other eye diseases impairing visual acuity (ie. glaucoma)

- patients with severe systemic diseases not good for ocular surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• MSSICS
Manual super small incision cataract surgery
• Phacoemulsification
cataract surgery with Phacoemulsification

Locations
Country Name City State
China Eye Hospital, Wenzhou Medical College Wenzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal endothelial cell loss 3 months postoperatively Yes
Secondary postoperative astigmatism 3 months postoperatively Yes
Secondary visual acuity 3 month postoperatively Yes
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