Comparing two vision corrective laser eye surgery techniques

Epithelial remodeling in Femtolasik Topoguided and customized asphericity in the contralateral eye: a randomized double-blind prospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78153726

Enrollment

Registered

2022-10-20

Start date

2019-04-30

Completion date

Unknown

Last updated

2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia with or without astigmatism Eye Diseases

Interventions

A randomized double trial: Topoguided femtolasik (contoura) will be performed in one eye and customized by asphericity (Custom-Q) in the contralateral eye. In January 2019, the design of the researc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Myopic patients with or without astigmatism 2. Aged between 20-35 years old 3. Spherical degree up to 8 and cylinder up to 3

Exclusion criteria

Exclusion criteria: 1. Keratoconus or predisposing topographic changes 2. Pachymetry below 500 3. PTA above 40 4. Previous eye surgery 5. Glaucoma 6. Dry eye 7. Cataract 8. Systemic diseases

Design outcomes

Primary

Measure	Time frame
Visual acuity (logMAR chart) measured using a digital projector with and without correction at 1 day, 1 month, and 3 months post-operatively	—

Secondary

Measure	Time frame
1. Ephthelial remodeling in microns measured using an OCT Avanti that evaluates the epithelial thickness map generated by an automatic algorithm and divided into a total of 17 sectors (central, paracentral and mid-periphery) preoperatively and at 3 months 2. Cornea total root mean square (RMS) (total high order aberrations on Cornea surface) measured using corneal tomography with the Galilei G6 using the Zernike map preoperatively and at 3 months postoperatively	—

Measure

Time frame

1. Ephthelial remodeling in microns measured using an OCT Avanti that evaluates the epithelial thickness map generated by an automatic algorithm and divided into a total of 17 sectors (central, paracentral and mid-periphery) preoperatively and at 3 months 2. Cornea total root mean square (RMS) (total high order aberrations on Cornea surface) measured using corneal tomography with the Galilei G6 using the Zernike map preoperatively and at 3 months postoperatively

—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026