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Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

Primary Purpose

Astigmatism, Cataract

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
phacoemulsification
Pentacam (Oculus,Germany)examination
Sponsored by
China Medical University, China
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Astigmatism focused on measuring astigmatism, pseudophakia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye hospital of China Medical UniverisityRecruiting

Outcomes

Primary Outcome Measures

Pentacam-derived corneal astigmatism
refraction

Secondary Outcome Measures

Full Information

First Posted
February 27, 2012
Last Updated
March 13, 2012
Sponsor
China Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01554761
Brief Title
Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
Official Title
Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism, Cataract
Keywords
astigmatism, pseudophakia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
phacoemulsification
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Pentacam (Oculus,Germany)examination
Intervention Description
Total corneal astigmatism is obtained by Pentacam at every visit.
Primary Outcome Measure Information:
Title
Pentacam-derived corneal astigmatism
Time Frame
3month postoperatively
Title
refraction
Time Frame
3month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Sun, MD
Phone
+86 15840336028
Email
qisun97@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsong Zhang, MD
Organizational Affiliation
Eye Hospital of China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye hospital of China Medical Univerisity
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsong Zhang, MD
Phone
+86 13066667486
First Name & Middle Initial & Last Name & Degree
Qi Sun, MD
First Name & Middle Initial & Last Name & Degree
Cheng Peng, MD
First Name & Middle Initial & Last Name & Degree
Jiangyue Zhao, MD
First Name & Middle Initial & Last Name & Degree
Liwei Ma, MD.PhD

12. IPD Sharing Statement

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Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

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