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Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

This study is currently recruiting participants.
Verified March 2012 by China Medical University, China
Sponsor:
Information provided by (Responsible Party):
Jinsong Zhang, China Medical University, China
ClinicalTrials.gov Identifier:
NCT01554761
First received: February 27, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

This study is to evaluate the necessity of considering posterior corneal toricity on refractive outcome of patients with cataracts and corneal astigmatism after implantation of intraocular lenses.

This is determined by comparing total corneal and refractive astigmatism,and by comparing the expected refractive result with actual refractive astigmatism postoperatively,using total corneal and anterior corneal astigmatism to calculate respectively.


Condition Intervention Phase
Astigmatism
Cataract
 Procedure: phacoemulsification
Device: Pentacam (Oculus,Germany)examination
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by China Medical University, China:

Primary Outcome Measures:
  • Pentacam-derived corneal astigmatism [ Time Frame: 3month postoperatively ] [ Designated as safety issue: No ]
  • refraction [ Time Frame: 3month postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: phacoemulsification
    After topical anesthesia with Alcaine, 3.0-mm clear corneal incisions were made. Torsional phacoemulsification was performed using the Infiniti Vision System with the OZil handpiece, a 45-degree Kelman miniflared tip, and DuoVisc viscoelastic (all from Alcon).
    Device: Pentacam (Oculus,Germany)examination
    Total corneal astigmatism is obtained by Pentacam at every visit.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cataract candidates
  • preoperative corneal regular astigmatism >0.75D
  • Willing and able to complete all required postoperative visits
  • Able to comprehend and sign a statement of informed consent

Exclusion Criteria:

  • significant intraocular lenses tilt or decentration
  • corneal scarring
  • Irregular corneal astigmatism
  • other ocular diseases
  • surgical complication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554761

Contacts
Contact: Qi Sun, MD +86 15840336028 qisun97@sina.com

Locations
China, Liaoning
Eye hospital of China Medical Univerisity Recruiting
Shenyang, Liaoning, China, 110005
Contact: Jinsong Zhang, MD     +86 13066667486        
Sub-Investigator: Qi Sun, MD            
Sub-Investigator: Cheng Peng, MD            
Sub-Investigator: Jiangyue Zhao, MD            
Sub-Investigator: Liwei Ma, MD.PhD            
Sponsors and Collaborators
China Medical University, China
Investigators
Principal Investigator: Jinsong Zhang, MD Eye Hospital of China Medical University
  More Information

No publications provided

Responsible Party: Jinsong Zhang, MD,the President of Eye hosptial of China Medical Univerisity,China, China Medical University, China
ClinicalTrials.gov Identifier: NCT01554761     History of Changes
Other Study ID Numbers: 2
Study First Received: February 27, 2012
Last Updated: March 13, 2012
Health Authority: China: Ministry of Health
United States: Food and Drug Administration

Keywords provided by China Medical University, China:
astigmatism
pseudophakia

Additional relevant MeSH terms:
Astigmatism
Pseudophakia
Cataract
Refractive Errors
 Eye Diseases
Signs and Symptoms
Lens Diseases

ClinicalTrials.gov processed this record on May 19, 2013