Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

January 2, 2014 updated by: Xiangtian Zhou, Wenzhou Medical University
The purpose of this study is to compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Eye Hospital, Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phacoemulsification, Safety, Efficacy
Procedure: Phacoemulsification
cataract surgery with Phacoemulsification
Experimental: MSSICS, Safety, Efficacy
Procedure: MSSICS
Manual super small incision cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Corneal endothelial cell loss
Time Frame: 3 months postoperatively
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative astigmatism
Time Frame: 3 months postoperatively
3 months postoperatively
visual acuity
Time Frame: 3 month postoperatively
3 month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Investigators

  • Principal Investigator: Wei Chen, MD, PhD, Eye Hospital, Wenzhou Medical College, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 17, 2010

First Posted (Estimate)

June 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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