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

Kasr El Aini Hospital

Status: Completed

Conditions: Myopia

Treatments: Procedure: PRK

Study type: Interventional

Funder types: Other

Identifiers

NCT03291873

900800700600500400300200100900

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

topography guided PRK in one eye

Active Comparator group

Description:

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

Treatment:

Procedure: PRK

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

Active Comparator group

Description:

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

Treatment:

Procedure: PRK