MyopiaNCT04854447
Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)
A study testing Single-Vision Spectacles in people with Myopia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Myopia
- What is being tested?
- Single-Vision Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 15 Nov 2019to 25 Nov 2021
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4 to 16 years old at the time of enrollment.
- Best-corrected visual acuity (BCVA) LogMAR 0.1 or better, in each eye.
- Cycloplegic Autorefraction: Myopia, SER between -0.50D and -6.00D, in each eye. Astigmatism less than or equal to 1.50D, in each eye. Anisometropia less than or equal to 1.50D between the two eyes.
- Absence of any ocular or systemic condition that could influence refractive development, other than myopia.
- Eagerness to participate in this study and receive myopia treatment in a randomized fashion. Availability for at least 1-year follow-up. Subject parent's or guardian's understanding of the protocol and acceptance to participate, providing a signed consent on behalf of the subject.
Who cannot join
- Presence of strabismus.
- Presence of amblyopia.
- Prematurity (gestational age less than 37 weeks).
- Presence of an ocular condition affecting refraction (ie. cataract, dislocated lens).
- Presence of a systemic condition affecting refraction (ie. Down syndrome, Marfan syndrome).
- Allergy to cyclopentolate. Severe ocular or systemic allergies.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control.
Read the detailed description
A prospective, randomized, controlled clinical trial was designed for assessing the effect of single-vision spectacles on myopic progression. 30 myopic subjects, aged 6-16 years old, with a spherical equivalent refraction between -0.50D and -6.00D, were recruited. A random number table was used to allocate participants into either a) part-time use of single-vision spectacles, or b) full-time use of single-vision spectacles. Part-time use was for 4-6 hours a day, 7 days a week for a year. Clinical assessment included follow-up at 6 months and at 12 months upon allocation. The primary outcomes were a) change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction, and b) change in axial eye length (AL). The secondary outcomes were a) change in choroidal thickness (ChT), and b) assessment of the subjective tolerance.
- Conditions
- Myopia
- Being tested
- Single-Vision Spectacles
- Keywords
- Myopia, Spectacles, Full-time correction, Part-time correction, Childhood
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Vision SpectaclesDevice
Spectacle correction for myopia treatment
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Part-time myopia correction with single-vision spectacles Receives: Device: Single-Vision Spectacles |
| Control Group | Active comparator | Full-time myopia correction with single-vision spectacles Receives: Device: Single-Vision Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction.
Measured: Baseline to 6-months, and baseline to 12-months.
Change in axial length (AL).
Measured: Baseline to 6-months, and baseline to 12-months.
Secondary outcomes (2)
Change in choroidal thickness (ChT).
Measured: Baseline to 6-months, and baseline to 12-months.
Subjective tolerance, as assessed using a standardized questionnaire created for the purpose of this study.
This questionnaire is formed by the researchers participating in this study and is aimed at providing a qualitative assessment of the subjective tolerance of included children wearing spectacles. It incorporates 6 questions and is not based on a scale.
Measured: Baseline to 12-months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start15 Nov 2019
- Primary completion28 Jun 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- State Scholarships Foundation
- Responsible party
- Principal investigator, Asimina Mataftsi, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854447
- Sponsor's protocol ID
- 2.68/27-02-2019
- Status last verified
- Dec 2021
- First submitted
- 18 Apr 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vasudevan B, Esposito C, Peterson C, Coronado C, Ciuffreda KJ. Under-correction of human myopia--is it myopigenic?: a retrospective analysis of clinical refraction data. J Optom. 2014 Jul-Sep;7(3):147-52. doi: 10.1016/j.optom.2013.12.007. Epub 2014 May 10.
PubMed 25000870Sun YY, Li SM, Li SY, Kang MT, Liu LR, Meng B, Zhang FJ, Millodot M, Wang N. Effect of uncorrection versus full correction on myopia progression in 12-year-old children. Graefes Arch Clin Exp Ophthalmol. 2017 Jan;255(1):189-195. doi: 10.1007/s00417-016-3529-1. Epub 2016 Oct 29.
PubMed 27796670Logan NS, Wolffsohn JS. Role of un-correction, under-correction and over-correction of myopia as a strategy for slowing myopic progression. Clin Exp Optom. 2020 Mar;103(2):133-137. doi: 10.1111/cxo.12978. Epub 2019 Dec 18.
PubMed 31854025
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Part-time Versus Full-time Spectacles for Myopia Control (ParMA Study)
- ClinicalTrials.gov ID
- NCT04854447
- Acronym / sponsor ID
- 2.68/27-02-2019
- Conditions
- Myopia
- Keywords
- Myopia, Spectacles, Full-time correction, Part-time correction, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- State Scholarships Foundation
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 22 Apr 2021 (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.
The purpose is to assess the effect of part-time compared to full-time spectacle use in juvenile myopia control.
Detailed description
A prospective, randomized, controlled clinical trial was designed for assessing the effect of single-vision spectacles on myopic progression. 30 myopic subjects, aged 6-16 years old, with a spherical equivalent refraction between -0.50D and -6.00D, were recruited. A random number table was used to allocate participants into either a) part-time use of single-vision spectacles, or b) full-time use of single-vision spectacles. Part-time use was for 4-6 hours a day, 7 days a week for a year. Clinical assessment included follow-up at 6 months and at 12 months upon allocation. The primary outcomes were a) change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction, and b) change in axial eye length (AL). The secondary outcomes were a) change in choroidal thickness (ChT), and b) assessment of the subjective tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: Single-Vision SpectaclesPart-time myopia correction with single-vision spectacles |
| Control Group | Active comparator | Device: Single-Vision SpectaclesFull-time myopia correction with single-vision spectacles |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 4 to 16 years old at the time of enrollment.
- Best-corrected visual acuity (BCVA) LogMAR 0.1 or better, in each eye.
- Cycloplegic Autorefraction: Myopia, SER between -0.50D and -6.00D, in each eye. Astigmatism less than or equal to 1.50D, in each eye. Anisometropia less than or equal to 1.50D between the two eyes.
- Absence of any ocular or systemic condition that could influence refractive development, other than myopia.
- Eagerness to participate in this study and receive myopia treatment in a randomized fashion. Availability for at least 1-year follow-up. Subject parent's or guardian's understanding of the protocol and acceptance to participate, providing a signed consent on behalf of the subject.
Key exclusion criteria (6 listed)
- Presence of strabismus.
- Presence of amblyopia.
- Prematurity (gestational age less than 37 weeks).
- Presence of an ocular condition affecting refraction (ie. cataract, dislocated lens).
- Presence of a systemic condition affecting refraction (ie. Down syndrome, Marfan syndrome).
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 |
|---|---|---|
| Single-Vision SpectaclesSpectacle correction for myopia treatment | Device | Control Group, Study Group |
Primary outcome
Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction.
Time frame: Baseline to 6-months, and baseline to 12-months.
Change in axial length (AL).
Time frame: Baseline to 6-months, and baseline to 12-months.
2 secondary outcomes
Change in choroidal thickness (ChT).
Time frame: Baseline to 6-months, and baseline to 12-months.
Subjective tolerance, as assessed using a standardized questionnaire created for the purpose of this study.
Time frame: Baseline to 12-months.
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 22 Dec 2021.
- Background: PubMed 25000870Vasudevan B, Esposito C, Peterson C, Coronado C, Ciuffreda KJ. Under-correction of human myopia--is it myopigenic?: a retrospective analysis of clinical refraction data. J Optom. 2014 Jul-Sep;7(3):147-52. doi: 10.1016/j.optom.2013.12.007. Epub 2014 May 10.
- Background: PubMed 27796670Sun YY, Li SM, Li SY, Kang MT, Liu LR, Meng B, Zhang FJ, Millodot M, Wang N. Effect of uncorrection versus full correction on myopia progression in 12-year-old children. Graefes Arch Clin Exp Ophthalmol. 2017 Jan;255(1):189-195. doi: 10.1007/s00417-016-3529-1. Epub 2016 Oct 29.
- Background: PubMed 31854025Logan NS, Wolffsohn JS. Role of un-correction, under-correction and over-correction of myopia as a strategy for slowing myopic progression. Clin Exp Optom. 2020 Mar;103(2):133-137. doi: 10.1111/cxo.12978. Epub 2019 Dec 18.
- 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 Single-Vision Spectacles in people with Myopia, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 5 inclusion and 6 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 22 Dec 2021. 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 Greece. 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?
Change in spherical equivalent refractive error (SER), measured using cycloplegic autorefraction. (time frame: Baseline to 6-months, and baseline to 12-months.). The study lists 2 primary outcomes in all. 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 NCT04854447, which also lists 3 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 22 Dec 2021; AzTrials last refreshed its copy on 30 Oct 2026.