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Trial record 24 of 181 for:    Recruiting, Not yet recruiting, Available Studies | "Corneal Diseases"

Accuracy of Corneal Astigmatism in Different Region Modes

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ClinicalTrials.gov Identifier: NCT03299530
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical University

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

Condition or disease Intervention/treatment
Astigmatism Cornea Other: patients with corneal astigmatism

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Accuracy of Corneal Astigmatism in Different Region Modes
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : November 10, 2018
Estimated Study Completion Date : December 15, 2018

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Vectorial difference [ Time Frame: ≥1 month after surgery ]
    The vectorial difference between measured corneal astigmatism (under multiple different region mode settings) and actual corneal astigmatism.

  2. pupil size [ Time Frame: ≥1 month after surgery ]
    pupil size of patients in a bright environment measured by itrace device and MONCV3 device

  3. pupil size 2 [ Time Frame: ≥1 month after surgery ]
    pupil size of patients measured by Pentacam HR device

  4. residual astigmatism [ Time Frame: ≥1 month after surgery ]
    residual astigmatism tested by subjective refraction

  5. total corneal astigmatism [ Time Frame: ≥1 month after surgery ]
    Total corneal astigmatism measured by a scheimpflug tomographer under different region mode settings.

  6. Anterior chamber depth [ Time Frame: ≥1 month after surgery ]
    The distance between corneal apex and anterior surface of IOL measured by a scheimpflug tomographer

  7. actual corneal astigmatism [ Time Frame: ≥1 month after surgery ]
    actual corneal astigmatism is derived from residual astigmatism at corneal plane and cylindrical power of IOL at corneal plane through Holladay 2 formula.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who received cataract surgery in The Eye Hospital of Wenzhou Medical University
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299530


Contacts
Contact: AYong Yu, MD.PhD. +86-0577-88068880 yaybetter@hotmail.com
Contact: Xu Shao, MD 564056712@qq.com

Locations
China, Zhejiang
Eye Hispital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Wenzhou Medical University
Investigators
Principal Investigator: AYong Yu, MD.PhD. Wenzhou Medical University

Responsible Party: A-Yong Yu, Director of the Cataract Clinical Center, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03299530     History of Changes
Other Study ID Numbers: 2017ASTIGMATISM REGIONS
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by A-Yong Yu, Wenzhou Medical University:
Corneal Astigmatism
Scheimpflug
pupil size
Toric

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases