NCT04589091

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

April 13, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

October 13, 2020

Last Update Submit

February 7, 2022

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

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

    Using the results of measurements of 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 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

    6 months

Study Arms (2)

Group(1): Patient who underwent PRK

Other: Refractive surgery

Group(2): Patient underwent LASIK

Other: Refractive surgery

Interventions

Refractive surgeryOTHER

Refractive surgery for correction of error of refraction

Group(1): Patient who underwent PRKGroup(2): Patient underwent LASIK

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

We will 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

You may qualify if:

  • Patients who underwent refractive surgery either PRK, LASIK with age between 19 and 35 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospital

Tanta, El-Garbeia, 31515, Egypt

Location

Related Publications (4)

  • Bailey MD, Zadnik K. Outcomes of LASIK for myopia with FDA-approved lasers. Cornea. 2007 Apr;26(3):246-54. doi: 10.1097/ICO.0b013e318033dbf0.

    PMID: 17413947RESULT

  • Sridhar MS, Rao SK, Vajpayee RB, Aasuri MK, Hannush S, Sinha R. Complications of laser-in-situ-keratomileusis. Indian J Ophthalmol. 2002 Dec;50(4):265-82.

    PMID: 12532491RESULT

  • Mohammadi SF, Nabovati P, Mirzajani A, Ashrafi E, Vakilian B. Risk factors of regression and undercorrection in photorefractive keratectomy: a case-control study. Int J Ophthalmol. 2015 Oct 18;8(5):933-7. doi: 10.3980/j.issn.2222-3959.2015.05.14. eCollection 2015.

    PMID: 26558204RESULT

  • Belin MW, Ambrosio R Jr. Corneal ectasia risk score: statistical validity and clinical relevance. J Refract Surg. 2010 Apr;26(4):238-40. doi: 10.3928/1081597X-20100318-01. No abstract available.

    PMID: 20415320RESULT

MeSH Terms

Conditions

Myopia

Interventions

Refractive Surgical Procedures

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of ophthalmology , Tanta University Hospital

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 19, 2020

Study Start

April 13, 2021

Primary Completion

October 30, 2021

Study Completion

January 30, 2022

Last Updated

February 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
3 months
Access Criteria
Link

Locations

EG(1)