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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014