Myopia and Astigmatism Topography-guided Refractive Surgery by Contoura Method Versus Customized by Asphericity in Contralateral Eyes: A Prospective Double-blind Randomized Study

Not Applicable

• Conditions: H52.2; Myopia and Astigmatism refractive Surgery in virgin eyes; H52.1; E02.594.480.750

• Registration Number: RBR-8rs5kt
• Lead Sponsor: Hospital de Olhos - Oftalmax

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients of both sexes aged 20-35 years (avoiding possibly presbyopia patients), myopic with or without astigmatism, with stable refractive error for at least 1 year and visual acuity corrected away from 0.1 logMAR or better. The myopia may vary between -0.50 and -8.00 diopters (D) and the astigmatism between 0.00 and -3.00 cylindrical diopters (CD), with maximum spherical equivalent of 8.00D.

Exclusion Criteria

Patients with significant anisometropia, that is a refractive difference of 1 spherical diopter or 0.75 cylindrical diopters between the eyes, will be excluded from the study. Other exclusion criteria will be: presence of clinical signs of dry eye, abnormalities of the anterior segment - such as cataracts, scars or corneal neovascularization within 1.0 mm of the desired ablation zone, epithelial basement membrane disease, history of recurrent corneal erosions, progressive or unstable myopia, PAT (percentage of altered tissue) calculation above 35% of the corneal thickness at its finest point in the ablation calculation19,24, pachymetry below 500, suspected keratoconus in its subclinical or stablished form, macular or retinal disease, diagnosis of glaucoma or ocular hypertension, current use of systemic corticosteroids or immunosuppressive therapy, collagen diseases, vascular diseases, diabetes mellitus types I and II, pregnancy and breastfeeding. The patient who presents any type of intraoperative intercurrence will be excluded from the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main variable to be studied is visual acuity without correction measured postoperatively. Eyes treated by topography-guided ablation (Contoura) should have a line-of-sight gain in visual acuity measurement greater than that of asphericity (Custom-Q);Both groups showed excellent results and did not show superiority in uncorrected visual acuity (UDVA)between eyes treated by Contoura and eyes treated by Custom-Q. In terms of methods’ difference, the average difference between Contoura and Custom-Q was 0,015 logMAR (Wald ?²(1) = 0.691, p-value = 0,406); therefore, we have lack of evidence regarding the difference between both methods across the time on the UDVA.