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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04924231
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Behavioral: astigmatism

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Effect of 1.8-mm Steep-axis Clear Corneal Incision on the Posterior Corneal Astigmatism in Candidates for Toric IOL Implantation
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Mar 30, 2018
• Actual Study Completion Date: May 1, 2018

Outcome Measures

Primary Outcome Measures

1. corneal astigmatism [post 1 month]

   postoperative anterior, posterior and total corneal astigmatism

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All

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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou		China

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04924231
• Other Study ID Numbers: 2020-407
• First Posted: Jun 11, 2021
• Last Update Posted: Jun 11, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract; Astigmatism

Study Results

No Results Posted as of Jun 11, 2021