Topography-Guided Customized PRK Versus Q-value Adjusted PRK in Correction of Myopia With or Without Astigmatism

NCT ID: NCT03291873

Last Updated: 2020-07-07

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

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-25

Study Completion Date

2019-06-25

Brief Summary

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This study will include patients who will undergo PRK in both eyes, for each patient each eye will be randomly allocated to one of 2 procedures:

topography-guided ablation in one eye (group I) and Q-factor customized ablation in the other eye (group II).

Alcon/Wavelight Light Laser Technolo¬gie (GmbH, Erlangen, Germany) will be used for photoablation.

The wavelight Topolyzer (Wavelight AG, Erlan¬gen, Germany)and CSO Sirius scheimpflug camera combined with Placido corneal topography (CSO, Florence,Italy) will be used before and 1, 3 and 6 months after PRK. Refrac¬tive visual outcomes and corneal aberration changes will be compared between the two treatment modalities.

Detailed Description

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Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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topography guided PRK in one eye

Topography-guided (placido disk- based) using T-CAT Contoura treatment.

Group Type ACTIVE_COMPARATOR

PRK

Intervention Type PROCEDURE

PRK using Alcon-Wavelight Excimer Laser EX 500

Q-value adjusted ( custom Q) PRK in the other eye

The target Q will be estimated according to a nomogram considering the patient's age

Group Type ACTIVE_COMPARATOR

PRK

Intervention Type PROCEDURE

PRK using Alcon-Wavelight Excimer Laser EX 500

Interventions

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PRK

PRK using Alcon-Wavelight Excimer Laser EX 500

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age more than 18 years
* Myopia with up to -6.5 D with or without astigmatism up to -4.75 D

Exclusion Criteria

* anterior segment abnormalities (ie, cataracts, corneal scarring)
* basement membrane disease
* history of recurrent corneal erosions
* Schirmer's test less than 5 mm
* established or forme fruste keratoconus
* macular or retinal disease
* current use of immunosuppressive therapy
* autoimmune disease
* pregnancy, and lactation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rania Elsayed Gad

Assisstant lecturer Faculty of Medicine Helwan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eyecare centre

Maadi, Cairo Governorate, Egypt

Site Status

Dar Al Oyun hospital

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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900800700600500400300200100900

Identifier Type: -

Identifier Source: org_study_id

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