Optical Quality of the Cornea in Orthokeratology

NCT06775509 | Completed FDA Device

• 1 other identifier: 27-09-23v1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Analyzing Optical Quality After the Use of Overnight Orthokeratology (Ortho-K)

Conditions

Myopia (Disorder); Astigmatism

Keywords

Ortho-K; Overnight Orthokeratology; Progression of Myopia; Myopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• OPTICAL QUALITY

  The primary outcome measure is the change in total corneal higher-order aberrations between baseline and 30 days of orthokeratology lens wear. It will be expressed using Zernike coefficients in microns.

  1 month after using Ortho-K

Study Arms (1)

Ortho - k

EXPERIMENTAL

The Utilization of Otho-K Contact lenses

Device: Ortho-K

Interventions

Ortho-K DEVICE

Utilization of Ortho-K Contact Lenses for The Treatment of Myopia

Ortho - k

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between 8 and 21 years old. Those who accept to participate in the study. The use of Ortho-K lenses for 8 to 10 hours per night, once the risks and benefits of using Ortho-K have been explained.
• Refractive error of myopia between -1.00 and -5.00 diopters (D) with astigmatism of 1.50 D or less, with-the-rule.
• Best-corrected visual acuity of 20/20 or better before treatment.
• Ortho-K lens centered or decentered by no more than 0.5 mm radially, determined by slit-lamp examination.

You may not qualify if:

• History of hard contact lens use and contraindications for ocular and systemic Ortho-K, determined by a routine examination.
• Patients who have previously undergone any refractive modulation procedure.
• Patients with any corneal pathology, dry eye, glaucoma, retinal pathology, strabismus, ptosis, amblyopia, history of ocular allergy, or infection.

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Clínica Licari Vision

Tarragona, Tarragona, 43001, Spain

Location

MeSH Terms

Conditions

Myopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Statistical Analysis
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophtalmologist Doctor

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 15, 2025
• Study Start: January 13, 2025
• Primary Completion: February 8, 2026
• Study Completion: February 28, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)