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Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01146964
First Posted: June 22, 2010
Last Update Posted: January 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xiangtian Zhou, Wenzhou Medical University
  Purpose
The purpose of this study is to compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.

Condition Intervention
Cataract Phacoemulsification Procedure: MSSICS Procedure: Phacoemulsification

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Xiangtian Zhou, Wenzhou Medical University:

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

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

Enrollment: 100
Study Start Date: May 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phacoemulsification, Safety, Efficacy Procedure: Phacoemulsification
cataract surgery with Phacoemulsification
Experimental: MSSICS, Safety, Efficacy Procedure: MSSICS
Manual super small incision cataract surgery

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: Xiangtian Zhou, MD, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01146964     History of Changes
Other Study ID Numbers: 10003
First Submitted: June 2, 2010
First Posted: June 22, 2010
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