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Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

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ClinicalTrials.gov Identifier: NCT01554761
Recruitment Status : Unknown
Verified March 2012 by Jinsong Zhang, China Medical University, China.
Recruitment status was:  Recruiting
First Posted : March 15, 2012
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):
Jinsong Zhang, China Medical University, China

Tracking Information
First Submitted Date  ICMJE February 27, 2012
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date March 15, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • Pentacam-derived corneal astigmatism [ Time Frame: 3month postoperatively ]
  • refraction [ Time Frame: 3month postoperatively ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
Official Title  ICMJE Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Astigmatism
  • Cataract
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 13, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01554761
Other Study ID Numbers  ICMJE 2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jinsong Zhang, China Medical University, China
Study Sponsor  ICMJE China Medical University, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jinsong Zhang, MD Eye Hospital of China Medical University
PRS Account China Medical University, China
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP