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Corneal Topography Asymmetry Indices Changes After Corneal Refractive Surgery

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT04589091
Collaborator
(none)
30
Enrollment
1
Location
9.6
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the changes that occur in the corneal indices after corneal refractive surgery either PRK or LASIK.

Condition or Disease Intervention/Treatment Phase
  • Other: Refractive surgery

Detailed Description

Retrospectively review the medical records of all patients who underwent refractive surgery referred from the out-patient clinic of Tanta University hospital between September 2015 and September 2020 .

Data collection will include:

Preoperative and postoperative Evaluation: Age, sex, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest and cycloplegic refraction, Slit lamp biomicroscopy, fundus examination.

Data of Corneal Tomography keratometric using Scheimpflug camera (Pentacam Oculus- Germany) :that includes the following indices

  1. Average keratometric value (K mean) in diopters

  2. Maximum simulated keratometry (Kmax) in diopters

  3. Index of Surface Variance (ISV) in microns

  4. Index of Vertical Asymmetey (IVA) in microns

  5. Radii Minimum (R min) in microns

  6. Index of height asymmetry (IHA) in microns

  7. Index of height decantation (IHD) in microns

  8. Aberration coefficient (ABR)

The data of the pentacam will be collected pre-operative and analyzed at 1 month, 3 months and 6 months with recording of the complications.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Corneal Topography Asymmetry Indices Changes After Corneal Refractive Surgery
Actual Study Start Date :
Apr 13, 2021
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Jan 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Group(1): Patient who underwent PRK

Other: Refractive surgery
Refractive surgery for correction of error of refraction
Group(2): Patient underwent LASIK

Other: Refractive surgery
Refractive surgery for correction of error of refraction

Outcome Measures

Primary Outcome Measures

  1. To evaluate the changes that occur in the corneal indices after corneal refractive surgery either PRK or LASIK. [6 months]

    Using the results of measurements of Scheimpflug camera (Pentacam Oculus- Germany) :that includes the following indices Average keratometric value (K mean) in diopters Maximum simulated keratometry (Kmax) in diopters Index of Surface Variance (ISV) in microns Index of Vertical Asymmetey (IVA) in microns Radii Minimum (R min) in microns Index of height asymmetry (IHA) in microns Index of height decantation (IHD) in microns Aberration coefficient (ABR) The numbers from preoperative records will be compared with postoperative records after the refractive surgery is done . All the values will be expressed as mean ± standard deviation and the data will be analyzed as 1 months, 3 months and 6 months after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who underwent refractive surgery either PRK, LASIK with age between 19 and 35 years old
Exclusion Criteria:

  • Kertoconus.

  • Corneal scarring.

  • Previous corneal infections.

  • Minimum corneal thickness at the thinnest location less than 400 µm.

  • History of uveitis or ocular allergy.

  • Pre-existing glaucoma.

  • Data not available

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Hospital Tanta El-Garbeia Egypt 31515

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dina Tadros, Lecturer of ophthalmology , Tanta University Hospital, Tanta University
ClinicalTrials.gov Identifier:
NCT04589091
Other Study ID Numbers:
  • 34081/9/20
First Posted:
Oct 19, 2020
Last Update Posted:
Feb 8, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myopia

Study Results

No Results Posted as of Feb 8, 2022