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Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

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ClinicalTrials.gov Identifier: NCT01146964
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : January 3, 2014
Sponsor:
Information provided by (Responsible Party):
Xiangtian Zhou, Wenzhou Medical University

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

Condition or disease Intervention/treatment Phase
Cataract Phacoemulsification Procedure: MSSICS Procedure: Phacoemulsification Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification
Study Start Date : May 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Corneal endothelial cell loss [ Time Frame: 3 months postoperatively ]

Secondary Outcome Measures :
  1. postoperative astigmatism [ Time Frame: 3 months postoperatively ]
  2. visual acuity [ Time Frame: 3 month postoperatively ]


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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146964


Locations
China, Zhejiang
Eye Hospital, Wenzhou Medical College
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: Wei Chen, MD, PhD Eye Hospital, Wenzhou Medical College, China

Responsible Party: Xiangtian Zhou, MD, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01146964     History of Changes
Other Study ID Numbers: 10003
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014

Keywords provided by Xiangtian Zhou, Wenzhou Medical University:
Age related cataract
Phacoemulsification
Manual super small incision cataract surgery

Additional relevant MeSH terms:
Cataract
Surgical Wound
Lens Diseases
Eye Diseases
Wounds and Injuries