Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiangtian Zhou, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01146964
First received: June 2, 2010
Last updated: January 2, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Wenzhou Medical University:

Primary Outcome Measures:
  • Corneal endothelial cell loss [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • postoperative astigmatism [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
  • visual acuity [ Time Frame: 3 month postoperatively ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Xiangtian Zhou, MD, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01146964     History of Changes
Other Study ID Numbers: 10003
Study First Received: June 2, 2010
Last Updated: January 2, 2014
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 22, 2014