Accuracy of Corneal Astigmatism in Different Region Modes

NCT03299530 | Recruiting

• 1 other identifier: 2017ASTIGMATISM REGIONS
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To analyze the difference between measured total corneal astigmatism and actual corneal astigmatism under different region modes and optimize the region setting.

Conditions

Astigmatism; Cornea

Keywords

Corneal Astigmatism; Scheimpflug; pupil size; Toric

Outcome Measures

Primary Outcomes (7)

• Vectorial difference

  The vectorial difference between measured corneal astigmatism (under multiple different region mode settings) and actual corneal astigmatism.

  ≥1 month after surgery

• pupil size

  pupil size of patients in a bright environment measured by itrace device and MONCV3 device

  ≥1 month after surgery

• pupil size 2

  pupil size of patients measured by Pentacam HR device

  ≥1 month after surgery

• residual astigmatism

  residual astigmatism tested by subjective refraction

  ≥1 month after surgery

• total corneal astigmatism

  Total corneal astigmatism measured by a scheimpflug tomographer under different region mode settings.

  ≥1 month after surgery

• Anterior chamber depth

  The distance between corneal apex and anterior surface of IOL measured by a scheimpflug tomographer

  ≥1 month after surgery

• actual corneal astigmatism

  actual corneal astigmatism is derived from residual astigmatism at corneal plane and cylindrical power of IOL at corneal plane through Holladay 2 formula.

  ≥1 month after surgery

Study Arms (1)

patients with corneal astigmatism

Patients who had received phacoemulsification surgery with or without implantation of toric IOL are with a certain amount of corneal astigmatism.

Other: patients with corneal astigmatism

Interventions

patients with corneal astigmatism OTHER

The total corneal astigmatism, anterior chamber depth, will be measured by a Scheimpflug tomographer. Pupil size will be measured by itrace device and MONCV3 device. Residual astigmatism will be tested by subjective refraction.

patients with corneal astigmatism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received cataract surgery in The Eye Hospital of Wenzhou Medical University

You may qualify if:

• Age ≥ 18 years
• Patients who had received phacoemulsification surgery with or without implantation of toric IOL are with a certain amount of corneal astigmatism.
• Best corrected visual acuity ≥ 0.66 (20/30 Snellen)

You may not qualify if:

• Corneal diseases or severe irregular astigmatism (e.g., pterygium, keratoconus), existence of corneal opacification;
• Ocular disease which may affect visual acuity (e.g., glaucoma, uveitis, retinal disease, pathologic myopia);
• History of ocular surgery or ocular trauma before this cataract surgery;
• Decentration of IOL \> 0.3mm or tilt \> 5°
• Implantation of multifocal IOL
• history of wearing of rigid contact lens within the past 4 weeks or soft contact lens within 1 week;

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Eye Hispital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Astigmatism; Corneal Diseases

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• AYong Yu, MD.PhD.

  Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AYong Yu, MD.PhD.

CONTACT

+86-0577-88068880; yaybetter@hotmail.com

Xu Shao, MD

CONTACT

564056712@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Cataract Clinical Center

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 3, 2017
• Study Start: October 10, 2017
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)