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Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

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. 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
Information provided by (Responsible Party):
Jinsong Zhang, China Medical University, China

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
Study Start Date : February 2012
Estimated Primary Completion Date : May 2012

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.

Primary Outcome Measures :
  1. Pentacam-derived corneal astigmatism [ Time Frame: 3month postoperatively ]
  2. refraction [ Time Frame: 3month postoperatively ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01554761

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Contact: Qi Sun, MD +86 15840336028

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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
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Principal Investigator: Jinsong Zhang, MD Eye Hospital of China Medical University
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Responsible Party: Jinsong Zhang, MD,the President of Eye hosptial of China Medical Univerisity,China, China Medical University, China Identifier: NCT01554761    
Other Study ID Numbers: 2
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012
Keywords provided by Jinsong Zhang, China Medical University, China:
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases
Refractive Errors