Corneal Topography Asymmetry Indices Changes After Corneal Refractive Surgery

NCT ID: NCT04589091

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-13

Study Completion Date

2022-01-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Myopia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group(1): Patient who underwent PRK

Refractive surgery

Intervention Type OTHER

Refractive surgery for correction of error of refraction

Group(2): Patient underwent LASIK

Refractive surgery

Intervention Type OTHER

Refractive surgery for correction of error of refraction

Interventions

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Refractive surgery

Refractive surgery for correction of error of refraction

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Dina Tadros

Lecturer of ophthalmology , Tanta University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University Hospital

Tanta, El-Garbeia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type RESULT
PMID: 17413947 (View on PubMed)

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.

Reference Type RESULT
PMID: 12532491 (View on PubMed)

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.

Reference Type RESULT
PMID: 26558204 (View on PubMed)

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.

Reference Type RESULT
PMID: 20415320 (View on PubMed)

Other Identifiers

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34081/9/20

Identifier Type: -

Identifier Source: org_study_id

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