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NCT04924231 Clinical Trial

Effect of 1.8-mm Steep-axis Clear Corneal Incision on the Posterior Corneal Astigmatism in Candidates for Toric IOL Implantation

Cataract Clinical Trial

Official title:
Effect of 1.8-mm Steep-axis Clear Corneal Incision on the Posterior Corneal Astigmatism in Candidates for Toric IOL Implantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04924231
Other study ID # 2020-407
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date May 1, 2018

Study information
Verified date June 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

we aimed to analyze the effects of cataract surgery using a 1.8-mm steep-axis clear corneal incision (CCI) on the posterior corneal surfaces based on the keratometry from the rotating Scheimpflug imaging device (Pentacam HR) in candidates for toric intraocular lens (IOL) implantation

Description:

Preoperative and at least 1-month postoperative data measured by Pentacam HR were collected in patients for toric IOL implantation. Surgically induced astigmatism on the posterior cornea (P-SIA) was calculated based on the preoperative and postoperative keratometric data, and the related factors of P-SIA were analyzed.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 1, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: 1. patients aged at least 45 years old who were scheduled for cataract surgery; (2) regular corneal astigmatism = 1.0 D; (3) the imaging quality parameter (QS) of Pentacam HR was "OK"; and (4) follow-up time =1.0 month. Exclusion Criteria:(1) irregular corneal astigmatism; (2) corneal scar, corneal degeneration, pterygium invading the optic zone; (3) corneal endothelium count<1,000/mm2, corneal endothelial dystrophy, iritis, glaucoma and retinal disease; (4) history of eye surgery, such as corneal refractive surgery, corneal transplantation and retinal surgery; (5) the main incision was expanded or sutures were used during surgery; and (6) some postoperative complications, such as persistent corneal edema, Descemet's membrane detachment and poor wound healing, and any others that might affect the measurement results of the Pentacam HR during the follow-up period. -

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• astigmatism
astigamatism at least 1 month after the cataract surgery

Locations
Country Name City State
China Second Affiliated Hospital, Zhejiang University School of Medicine Hangzhou

Sponsors (1)
Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary corneal astigmatism postoperative anterior, posterior and total corneal astigmatism post 1 month
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