Myopia (Disorder)COPCORTONCT06775509
Optical Quality of the Cornea in Orthokeratology
A study testing Ortho-K in people with Myopia (Disorder) and Astigmatism, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
Analyzing Optical Quality After the Use of Overnight Orthokeratology (Ortho-K) Read more about this study
- Who is it for?
- Ages 12 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia (Disorder), Astigmatism
- What is being tested?
- Ortho-K
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Analyzing Optical Quality After the Use of Overnight Orthokeratology (Ortho-K)
Read the detailed description
Optical Quality of the Cornea in Orthokeratology
Influence of changes in total corneal refractive power, corneal asphericity, and epithelial thickness.
Introduction:
The cornea is the transparent and avascular tissue of the eye, consisting of five layers: the corneal epithelium, Bowman's membrane, the stroma, Descemet's membrane, and the endothelium. Its thickness varies, being thinner at the central level, approximately 520 microns (0.52 mm), and about 1 mm near the sclera.
The corneal epithelium, the outermost layer, not only provides strong protective functions but also plays a role in corneal refractive function. In particular, the central corneal epithelium is especially important for corneal refraction. The refractive action of any optical surface is governed by two main parameters: the curvature of its surface and the difference in refractive indices of the media it separates.
Unlike other ocular media, the cornea is considered a refractive surface, as most refraction occurs at its anterior surface. This is due to the significant difference in the refractive index between air (n=1) and the corneal interior (n=1.376), which provides a refractive power of approximately 49 diopters. The posterior surface of the cornea, on the other hand, separates two media with very similar indices; the aqueous humor (n=1.336) has a slightly lower index than the cornea, reducing the overall refractive power of the cornea to about 43 diopters.
Asphericity is a characteristic of the cornea, with the central part being more curved than the peripheral zone. The Q value measures the corneal asphericity index (Q = 0 for spherical corneas, Q < 0 for prolate corneas, and Q > 0 for oblate corneas). The human cornea typically has a prolate shape (average negative Q value of - 0.27).
The Q value is based on a central curvature of 3 to 4 mm of the cornea. It is a coefficient that describes the rate of curvature change from the center to the periphery based on corneal radius values. The normal shape of the cornea is not a sphere but a prolate ellipse, meaning its curvature flattens as movement occurs from the center to the periphery. Prolate corneas, which are flatter in the periphery (negative Q values), reduce spherical aberrations due to their curvature. Conversely, oblate corneas, with positive Q values and a more curved periphery than the central part, increase spherical aberrations.
Orthokeratology (Ortho-K) is a clinical technique that temporarily reshapes the cornea to eliminate or reduce refractive errors. Ortho-K lenses are commonly worn during sleep (overnight orthokeratology) and removed immediately upon waking, allowing clear vision without assistance throughout the day. These lenses are made of rigid gas-permeable (RGP) material and aim to reduce myopia by flattening the cornea. This treatment is reversible, safe, and FDA-approved.
Although orthokeratology reduces myopia and provides good uncorrected vision during the day, numerous studies have shown that the combination of central corneal flattening and mid-peripheral corneal thickening leads to a significant increase in higher-order aberrations, resulting in a decrease in visual quality.
From a more physical perspective, light can be defined as an electromagnetic wave characterized by a wavefront. A wavefront is the surface where all points of the medium are reached by the wave at the same time. It is inferred that the wavefront is the surface formed by all points with the same phase as the wave propagates. The direction of a ray is always perpendicular to the wavefront.
The term aberration refers to deviation or distortion. Any alteration or change in the wavefront as it passes through an optical medium (ocular or otherwise) causes non-ideal propagation, resulting in wavefront aberration. The difference between the ideal and aberrated paths is known as wavefront aberration or wavefront error. Wavefront aberrations can be described using Zernike polynomials to specify ocular aberrations, allowing any aberration to be expressed in this way.
With orthokeratology, higher-order corneal aberrations increase significantly, especially spherical aberration. These increases correlate with the degree of myopic correction. Several studies have concluded that the loss of optical quality is most noticeable within the first month and becomes insignificant in subsequent months. After short-term corneal reshaping, optical quality decreases to a certain degree, but the loss is acceptable.
As mentioned earlier, orthokeratology causes central corneal epithelial thinning and mid-peripheral epithelial thickening. Changes in epithelial thickness show a non-uniform pattern, with greater thinning in the temporal and inferior zones compared to the nasal and superior zones in the paracentral region, and greater thickening in the nasal zone compared to the temporal zone in the mid-periphery.
Main Objective:
To analyze the optical quality of the cornea after changes induced in its shape and structure by overnight orthokeratology.
To achieve this, the following will be analyzed:
Changes in the various refractive maps obtained using the Pentacam topography system.
Corneal aberrations obtained through Zernike analysis of both corneal surfaces. The changes in the anterior corneal asphericity and its correlation with induced spherical aberration will also be analyzed.
Changes in central and peripheral epithelial thickness and their correlation with changes in corneal asphericity and induced aberrations evaluated using corneal OCT.
Changes in the aforementioned variables between morning and late afternoon (daily regression).
In all cases, the results will also be correlated with ocular refraction obtained under cycloplegia.
- Conditions
- Myopia (Disorder), Astigmatism
- Being tested
- Ortho-K
- Keywords
- Ortho-K, Overnight Orthokeratology, Progression of Myopia, Myopia, Astigmatism
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ortho-KDevice
Utilization of Ortho-K Contact Lenses for The Treatment of Myopia
| Study group | Role | What they receive |
|---|---|---|
| Ortho - k | Experimental | The Utilization of Otho-K Contact lenses Receives: Device: Ortho-K |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after using Ortho-K
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start13 Jan 2025
- Primary completion8 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myopia (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Licari, Institut Investigacio Sanitaria Pere Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775509
- Sponsor's protocol ID
- 27-09-23v1
- Acronym
- COPCORTO
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Licari J, Medico-Salsench A, Medina-Guijarro L, Villa-Collar C, Rey-Renones C. Optical Quality of the Cornea After Orthokeratology Based on Total Corneal Refractive Power, Corneal Asphericity, and Epithelial Thickness: Protocol for a Prospective Quasi-Experimental Pre-Post Study. JMIR Res Protoc. 2026 Aug 12;15:e94476. doi: 10.2196/94476.
PubMed 42585035
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Quality of the Cornea in Orthokeratology
- ClinicalTrials.gov ID
- NCT06775509
- Acronym / sponsor ID
- COPCORTO / 27-09-23v1
- Conditions
- Myopia (Disorder), Astigmatism
- Keywords
- Ortho-K, Overnight Orthokeratology, Progression of Myopia, Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 8 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analyzing Optical Quality After the Use of Overnight Orthokeratology (Ortho-K)
Detailed description
Optical Quality of the Cornea in Orthokeratology
Influence of changes in total corneal refractive power, corneal asphericity, and epithelial thickness.
Introduction:
The cornea is the transparent and avascular tissue of the eye, consisting of five layers: the corneal epithelium, Bowman's membrane, the stroma, Descemet's membrane, and the endothelium. Its thickness varies, being thinner at the central level, approximately 520 microns (0.52 mm), and about 1 mm near the sclera.
The corneal epithelium, the outermost layer, not only provides strong protective functions but also plays a role in corneal refractive function. In particular, the central corneal epithelium is especially important for corneal refraction. The refractive action of any optical surface is governed by two main parameters: the curvature of its surface and the difference in refractive indices of the media it separates.
Unlike other ocular media, the cornea is considered a refractive surface, as most refraction occurs at its anterior surface. This is due to the significant difference in the refractive index between air (n=1) and the corneal interior (n=1.376), which provides a refractive power of approximately 49 diopters. The posterior surface of the cornea, on the other hand, separates two media with very similar indices; the aqueous humor (n=1.336) has a slightly lower index than the cornea, reducing the overall refractive power of the cornea to about 43 diopters.
Asphericity is a characteristic of the cornea, with the central part being more curved than the peripheral zone. The Q value measures the corneal asphericity index (Q = 0 for spherical corneas, Q < 0 for prolate corneas, and Q > 0 for oblate corneas). The human cornea typically has a prolate shape (average negative Q value of - 0.27).
The Q value is based on a central curvature of 3 to 4 mm of the cornea. It is a coefficient that describes the rate of curvature change from the center to the periphery based on corneal radius values. The normal shape of the cornea is not a sphere but a prolate ellipse, meaning its curvature flattens as movement occurs from the center to the periphery. Prolate corneas, which are flatter in the periphery (negative Q values), reduce spherical aberrations due to their curvature. Conversely, oblate corneas, with positive Q values and a more curved periphery than the central part, increase spherical aberrations.
Orthokeratology (Ortho-K) is a clinical technique that temporarily reshapes the cornea to eliminate or reduce refractive errors. Ortho-K lenses are commonly worn during sleep (overnight orthokeratology) and removed immediately upon waking, allowing clear vision without assistance throughout the day. These lenses are made of rigid gas-permeable (RGP) material and aim to reduce myopia by flattening the cornea. This treatment is reversible, safe, and FDA-approved.
Although orthokeratology reduces myopia and provides good uncorrected vision during the day, numerous studies have shown that the combination of central corneal flattening and mid-peripheral corneal thickening leads to a significant increase in higher-order aberrations, resulting in a decrease in visual quality.
From a more physical perspective, light can be defined as an electromagnetic wave characterized by a wavefront. A wavefront is the surface where all points of the medium are reached by the wave at the same time. It is inferred that the wavefront is the surface formed by all points with the same phase as the wave propagates. The direction of a ray is always perpendicular to the wavefront.
The term aberration refers to deviation or distortion. Any alteration or change in the wavefront as it passes through an optical medium (ocular or otherwise) causes non-ideal propagation, resulting in wavefront aberration. The difference between the ideal and aberrated paths is known as wavefront aberration or wavefront error. Wavefront aberrations can be described using Zernike polynomials to specify ocular aberrations, allowing any aberration to be expressed in this way.
With orthokeratology, higher-order corneal aberrations increase significantly, especially spherical aberration. These increases correlate with the degree of myopic correction. Several studies have concluded that the loss of optical quality is most noticeable within the first month and becomes insignificant in subsequent months. After short-term corneal reshaping, optical quality decreases to a certain degree, but the loss is acceptable.
As mentioned earlier, orthokeratology causes central corneal epithelial thinning and mid-peripheral epithelial thickening. Changes in epithelial thickness show a non-uniform pattern, with greater thinning in the temporal and inferior zones compared to the nasal and superior zones in the paracentral region, and greater thickening in the nasal zone compared to the temporal zone in the mid-periphery.
Main Objective:
To analyze the optical quality of the cornea after changes induced in its shape and structure by overnight orthokeratology.
To achieve this, the following will be analyzed:
Changes in the various refractive maps obtained using the Pentacam topography system.
Corneal aberrations obtained through Zernike analysis of both corneal surfaces. The changes in the anterior corneal asphericity and its correlation with induced spherical aberration will also be analyzed.
Changes in central and peripheral epithelial thickness and their correlation with changes in corneal asphericity and induced aberrations evaluated using corneal OCT.
Changes in the aforementioned variables between morning and late afternoon (daily regression).
In all cases, the results will also be correlated with ocular refraction obtained under cycloplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ortho - k | Experimental | Device: Ortho-KThe Utilization of Otho-K Contact lenses |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ortho-KUtilization of Ortho-K Contact Lenses for The Treatment of Myopia | Device | Ortho - k |
Primary outcome
OPTICAL QUALITY
Time frame: 1 month after using Ortho-K
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Derived from this study: PubMed 42585035Licari J, Medico-Salsench A, Medina-Guijarro L, Villa-Collar C, Rey-Renones C. Optical Quality of the Cornea After Orthokeratology Based on Total Corneal Refractive Power, Corneal Asphericity, and Epithelial Thickness: Protocol for a Prospective Quasi-Experimental Pre-Post Study. JMIR Res Protoc. 2026 Aug 12;15:e94476. doi: 10.2196/94476.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ortho-K in people with Myopia (Disorder) and Astigmatism, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OPTICAL QUALITY (time frame: 1 month after using Ortho-K). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06775509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.