Myopia, ProgressiveNCT05773118
A Unified Index to Predict the Success Probability of Myopia Control
A study testing orthokeratology lens, multifocal soft contact lens and Single vision spectacles in people with Myopia, Progressive, run by Nova Southeastern University.
Trial summary
Orthokeratology lenses (OK-lens) and multifocal contact lenses (MFCL) are optical devices designed to slow down the progression of myopia. Both treatments a long-term commitment from doctors and patients. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- orthokeratology lens, multifocal soft contact lens and Single vision spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jan 2030
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Older than 7 years of age or younger than 12 years of age,
- Spherical equivalent (SE) greater -1.00 D and less than-5.00 D,
- Corneal astigmatism ≤ 1.50 D,
- best-corrected visual acuity better than 20/25,
- No binocular vision dysfunction,
- No obvious angle kappa,
Show all 9Show fewer
- No history of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days,
- No contact lens contraindications,
- No related ocular or systemic disease.
Who cannot join
- Younger than 7 years of age or older than 12 years of age,
- Spherical equivalent (SE) less than -1.00 D or greater than-5.00 D,
- Corneal astigmatism > 1.50 D,
- Best-corrected visual acuity less than 20/25,
- Binocular vision dysfunction,
- Obvious angle kappa,
Show all 9Show fewer
- History of an OK-lens or MFCL wear or any other myopia control treatments such as atropine, application of atropine for cycloplegia during the past 30 days,
- Contact lens contraindications,
- Related ocular or systemic disease.
About this study
Orthokeratology lenses (OK-lens) and multifocal contact lenses (MFCL) are optical devices designed to slow down the progression of myopia. Both treatments a long-term commitment from doctors and patients. This study aims to develop a unified index to predict the success probability of myopia control at the early stage of treatment.
Read the detailed description
An Orthokeratology lens (OK-lens) is a rigid contact lens with a reverse geometry on its back surface. Overnight OK-lens wearing flattens the central cornea (creating minus power) and steepens the mid-peripheral cornea (creating plus power). During the day, this inverted pattern of peripheral corneal refraction induces relative peripheral myopic defocus on the retina to slow down the axial growth. The central portion of an MFCL is designed with minus powers to correct for distance vision, and plus power is directly added to the peripheral part of the lens. Daytime MFCL wear imposes peripheral retinal myopic defocus when the lenses are worn. An MFCL can also reduce axial growth by 52% compared to a single vision spectacle or contact lens.
Myopia control with OK-lens or MFCL requires a long-term commitment from doctors and patients to see the effect become apparent. It is paramount to estimate the probability that a patient would achieve effective control in myopic progression ideally before treatment begins or early during the course of treatment. To this end, efforts have been made to investigate the correlations between axial growth and possible contributing factors. Early research works have covered a variety of parameters at the baseline, including age, spherical equivalent (SE), corneal eccentricity, and corneal thickness. These measurements are nonspecific, indirect, and based on the assumption that their relationships to axial growth are linear, which often leads to contradictory findings and results that are hard to interpret by physicians. Therefore, in this study, we proposed a new index that takes pupil size into consideration by determining the summed relative myopic defocus dosage within the pupillary area (PMDD) to predict myopia control's success rate. This index will be determined for each eye, will be quantified one month after the lens dispensing, and will be used as the predictive variable.
- Conditions
- Myopia, Progressive
- Being tested
- orthokeratology lens, multifocal soft contact lens, Single vision spectacles
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthokeratology lensDevice
Subjects will wear orthokeratology lens at night. Axial length elongation over a period of 12-month will be recorded.
multifocal soft contact lensDevice
Subjects will wear multifocal soft contact lens during the day time. Axial length elongation over a period of 12-month will be recorded.
Single vision spectaclesDevice
Subjects will wear single vision spectacles during the day. Axial length elongation over a period of 12-month will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| orthokeratology lens | Experimental | The subjects will wear an orthokeratology lens with 3-zone reverse geometry design. The subjects are instructed to wear the lenses for at least eight hours every night and are removed during daytime hours. Receives: Device: orthokeratology lens |
| multifocal soft contact lens | Experimental | The subjects will wear a multifocal soft contact lens during daytime hours and remove the lens at night Receives: Device: multifocal soft contact lens |
| single vision spectacle | Active comparator | The subjects will wear single vision spectacle lens as control. Receives: Device: Single vision spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
axial length elongation
The changes in axial length at the end of 12-month treatment will be computed.
Measured: over 12 months
Secondary outcomes (1)
pupillary myopia defocus dosage
The myopia defocus dosage accumulated within the pupillary area
Measured: over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study startJan 2025 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Why it stopped: Recent personnel changes in the research team make it unrealistic to conduct this research project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myopia, ProgressiveStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773118
- Sponsor's protocol ID
- 2022-597
- Status last verified
- Sep 2023
- First submitted
- 6 Mar 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wang D, Wen D, Zhang B, Lin W, Liu G, Du B, Lin F, Li X, Wei R. The Association between Fourier Parameters and Clinical Parameters in Myopic Children Undergoing Orthokeratology. Curr Eye Res. 2021 Nov;46(11):1637-1645. doi: 10.1080/02713683.2021.1917619. Epub 2021 Jun 6.
PubMed 34096430Xia R, Su B, Bi H, Tang J, Lin Z, Zhang B, Jiang J. Good Visual Performance Despite Reduced Optical Quality during the First Month of Orthokeratology Lens Wear. Curr Eye Res. 2020 Apr;45(4):440-449. doi: 10.1080/02713683.2019.1668950. Epub 2019 Sep 24.
PubMed 31526284Yang X, Bi H, Li L, Li S, Chen S, Zhang B, Wang Y. The Effect of Relative Corneal Refractive Power Shift Distribution on Axial Length Growth in Myopic Children Undergoing Orthokeratology Treatment. Curr Eye Res. 2021 May;46(5):657-665. doi: 10.1080/02713683.2020.1820528. Epub 2020 Sep 18.
PubMed 32945207Liu G, Wu Y, Bi H, Wang B, Gu T, Du B, Tong J, Zhang B, Wei R. Time Course of Perceived Visual Distortion and Axial Length Growth in Myopic Children Undergoing Orthokeratology. Front Neurosci. 2021 Oct 13;15:693217. doi: 10.3389/fnins.2021.693217. eCollection 2021.
PubMed 34720848Lin W, Gu T, Bi H, Du B, Zhang B, Wei R. The treatment zone decentration and corneal refractive profile changes in children undergoing orthokeratology treatment. BMC Ophthalmol. 2022 Apr 18;22(1):177. doi: 10.1186/s12886-022-02396-w.
PubMed 35436922Jiang F, Huang X, Xia H, Wang B, Lu F, Zhang B, Jiang J. The Spatial Distribution of Relative Corneal Refractive Power Shift and Axial Growth in Myopic Children: Orthokeratology Versus Multifocal Contact Lens. Front Neurosci. 2021 Jun 9;15:686932. doi: 10.3389/fnins.2021.686932. eCollection 2021.
PubMed 34177459Liu G, Jin N, Bi H, Du B, Gu T, Zhang B, Wei R. Long-Term Changes in Straylight Induced by Overnight Orthokeratology: An Objective Measure Using the Double-Pass System. Curr Eye Res. 2019 Jan;44(1):11-18. doi: 10.1080/02713683.2018.1514056. Epub 2018 Sep 10.
PubMed 30198800
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Unified Index to Predict the Success Probability of Myopia Control
- ClinicalTrials.gov ID
- NCT05773118
- Acronym / sponsor ID
- 2022-597
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recent personnel changes in the research team make it unrealistic to conduct this research project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 17 Mar 2023 (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.
Orthokeratology lenses (OK-lens) and multifocal contact lenses (MFCL) are optical devices designed to slow down the progression of myopia. Both treatments a long-term commitment from doctors and patients. This study aims to develop a unified index to predict the success probability of myopia control at the early stage of treatment.
Detailed description
An Orthokeratology lens (OK-lens) is a rigid contact lens with a reverse geometry on its back surface. Overnight OK-lens wearing flattens the central cornea (creating minus power) and steepens the mid-peripheral cornea (creating plus power). During the day, this inverted pattern of peripheral corneal refraction induces relative peripheral myopic defocus on the retina to slow down the axial growth. The central portion of an MFCL is designed with minus powers to correct for distance vision, and plus power is directly added to the peripheral part of the lens. Daytime MFCL wear imposes peripheral retinal myopic defocus when the lenses are worn. An MFCL can also reduce axial growth by 52% compared to a single vision spectacle or contact lens.
Myopia control with OK-lens or MFCL requires a long-term commitment from doctors and patients to see the effect become apparent. It is paramount to estimate the probability that a patient would achieve effective control in myopic progression ideally before treatment begins or early during the course of treatment. To this end, efforts have been made to investigate the correlations between axial growth and possible contributing factors. Early research works have covered a variety of parameters at the baseline, including age, spherical equivalent (SE), corneal eccentricity, and corneal thickness. These measurements are nonspecific, indirect, and based on the assumption that their relationships to axial growth are linear, which often leads to contradictory findings and results that are hard to interpret by physicians. Therefore, in this study, we proposed a new index that takes pupil size into consideration by determining the summed relative myopic defocus dosage within the pupillary area (PMDD) to predict myopia control's success rate. This index will be determined for each eye, will be quantified one month after the lens dispensing, and will be used as the predictive variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| orthokeratology lens | Experimental | Device: orthokeratology lensThe subjects will wear an orthokeratology lens with 3-zone reverse geometry design. The subjects are instructed to wear the lenses for at least eight hours every night and are removed during daytime hours. |
| multifocal soft contact lens | Experimental | Device: multifocal soft contact lensThe subjects will wear a multifocal soft contact lens during daytime hours and remove the lens at night |
| single vision spectacle | Active comparator | Device: Single vision spectaclesThe subjects will wear single vision spectacle lens as control. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Older than 7 years of age or younger than 12 years of age,
- Spherical equivalent (SE) greater -1.00 D and less than-5.00 D,
- Corneal astigmatism ≤ 1.50 D,
- best-corrected visual acuity better than 20/25,
- No binocular vision dysfunction,
Key exclusion criteria (9 listed)
- Younger than 7 years of age or older than 12 years of age,
- Spherical equivalent (SE) less than -1.00 D or greater than-5.00 D,
- Corneal astigmatism > 1.50 D,
- Best-corrected visual acuity less than 20/25,
- Binocular vision dysfunction,
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 |
|---|---|---|
| orthokeratology lensSubjects will wear orthokeratology lens at night. Axial length elongation over a period of 12-month will be recorded. | Device | orthokeratology lens |
| multifocal soft contact lensSubjects will wear multifocal soft contact lens during the day time. Axial length elongation over a period of 12-month will be recorded. | Device | multifocal soft contact lens |
| Single vision spectaclesSubjects will wear single vision spectacles during the day. Axial length elongation over a period of 12-month will be recorded. | Device | single vision spectacle |
Primary outcome
axial length elongation
Time frame: over 12 months
The changes in axial length at the end of 12-month treatment will be computed.
1 secondary outcome
pupillary myopia defocus dosage
Time frame: over 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 34096430Wang D, Wen D, Zhang B, Lin W, Liu G, Du B, Lin F, Li X, Wei R. The Association between Fourier Parameters and Clinical Parameters in Myopic Children Undergoing Orthokeratology. Curr Eye Res. 2021 Nov;46(11):1637-1645. doi: 10.1080/02713683.2021.1917619. Epub 2021 Jun 6.
- Background: PubMed 31526284Xia R, Su B, Bi H, Tang J, Lin Z, Zhang B, Jiang J. Good Visual Performance Despite Reduced Optical Quality during the First Month of Orthokeratology Lens Wear. Curr Eye Res. 2020 Apr;45(4):440-449. doi: 10.1080/02713683.2019.1668950. Epub 2019 Sep 24.
- Background: PubMed 32945207Yang X, Bi H, Li L, Li S, Chen S, Zhang B, Wang Y. The Effect of Relative Corneal Refractive Power Shift Distribution on Axial Length Growth in Myopic Children Undergoing Orthokeratology Treatment. Curr Eye Res. 2021 May;46(5):657-665. doi: 10.1080/02713683.2020.1820528. Epub 2020 Sep 18.
- Background: PubMed 34720848Liu G, Wu Y, Bi H, Wang B, Gu T, Du B, Tong J, Zhang B, Wei R. Time Course of Perceived Visual Distortion and Axial Length Growth in Myopic Children Undergoing Orthokeratology. Front Neurosci. 2021 Oct 13;15:693217. doi: 10.3389/fnins.2021.693217. eCollection 2021.
- Background: PubMed 35436922Lin W, Gu T, Bi H, Du B, Zhang B, Wei R. The treatment zone decentration and corneal refractive profile changes in children undergoing orthokeratology treatment. BMC Ophthalmol. 2022 Apr 18;22(1):177. doi: 10.1186/s12886-022-02396-w.
- Background: PubMed 34177459Jiang F, Huang X, Xia H, Wang B, Lu F, Zhang B, Jiang J. The Spatial Distribution of Relative Corneal Refractive Power Shift and Axial Growth in Myopic Children: Orthokeratology Versus Multifocal Contact Lens. Front Neurosci. 2021 Jun 9;15:686932. doi: 10.3389/fnins.2021.686932. eCollection 2021.
- Background: PubMed 30198800Liu G, Jin N, Bi H, Du B, Gu T, Zhang B, Wei R. Long-Term Changes in Straylight Induced by Overnight Orthokeratology: An Objective Measure Using the Double-Pass System. Curr Eye Res. 2019 Jan;44(1):11-18. doi: 10.1080/02713683.2018.1514056. Epub 2018 Sep 10.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing orthokeratology lens, multifocal soft contact lens and Single vision spectacles in people with Myopia, Progressive, run by Nova Southeastern University.
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 9 inclusion and 9 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: withdrawn, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
axial length elongation (time frame: over 12 months). 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 NCT05773118, which also lists 7 linked publications.
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 13 Sep 2023.