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Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

Primary Purpose

Cataract, Phacoemulsification

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MSSICS
Phacoemulsification
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Age related cataract, Phacoemulsification, Manual super small incision cataract surgery

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Hospital, Wenzhou Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phacoemulsification, Safety, Efficacy

MSSICS, Safety, Efficacy

Arm Description

Outcomes

Primary Outcome Measures

Corneal endothelial cell loss

Secondary Outcome Measures

postoperative astigmatism
visual acuity

Full Information

First Posted
June 2, 2010
Last Updated
January 2, 2014
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01146964
Brief Title
Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification
Official Title
Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Phacoemulsification
Keywords
Age related cataract, Phacoemulsification, Manual super small incision cataract surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phacoemulsification, Safety, Efficacy
Arm Type
Experimental
Arm Title
MSSICS, Safety, Efficacy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MSSICS
Intervention Description
Manual super small incision cataract surgery
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification
Intervention Description
cataract surgery with Phacoemulsification
Primary Outcome Measure Information:
Title
Corneal endothelial cell loss
Time Frame
3 months postoperatively
Secondary Outcome Measure Information:
Title
postoperative astigmatism
Time Frame
3 months postoperatively
Title
visual acuity
Time Frame
3 month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Chen, MD, PhD
Organizational Affiliation
Eye Hospital, Wenzhou Medical College, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Hospital, Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China

12. IPD Sharing Statement

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Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

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