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
• Status: Completed
• 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
• 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
• 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.

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Related Conditions & MeSH terms

• Astigmatism
• Cataract

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