Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

Cataract Clinical Trial

Official title:

Effect of Posterior Corneal Toricity on Refractive Outcome of Pseudophakia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01554761
• Other study ID #: 2
• Status: Recruiting
• Phase: Phase 4
• First received: February 27, 2012
• Last updated: March 13, 2012
• Start date: February 2012

Study information

• Verified date: March 2012
• Source: China Medical University, China
• Contact: Qi Sun, MD
• Phone: +86 15840336028
• Email: qisun97[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Pseudophakia

Intervention

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.

Locations

Country	Name	City	State
China	Eye hospital of China Medical Univerisity	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pentacam-derived corneal astigmatism		3month postoperatively	No
Primary	refraction		3month postoperatively	No