Visual performance of three myopia control spectacles for children in China
| ISRCTN | ISRCTN50468704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50468704 |
| Secondary identifying numbers | CPRO-2211-001 |
- Submission date
- 06/06/2023
- Registration date
- 08/06/2023
- Last edited
- 16/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
The purpose of this observational study is to evaluate the ‘visual performance’ of 3 myopia (short-sightedness) control spectacle lenses worn for 1 to 2 weeks period. Visual performance in this study means how well the wearers can see, how quickly they can read and if they see halos through the spectacle lenses.
Who can participate?
Healthy myopic children aged 6 to 14 years old with non-diseased eyes.
What does the study involve?
There are up to five study visits over an eight-week period, one visit every 2 weeks. Participants will be wearing 3 different types of commercially available myopia control spectacle lenses in their prescription in a random fashion for 1 to 2 weeks. Each visit will be about 1.5 hour. At each visit, using Aston Vision iPad App, participants will be reading letters on a letter chart to measure vision, reading sentences to measure reading speed, to see if halos are present and obtaining feedback on their experience each of the spectacles worn using questionnaires.
What are the possible benefits and risks of participating?
The participants may not directly benefit from participating in the study. They will have the opportunity to try three different types of myopia control spectacles and choose the one they prefer. The examination and assessment of their eyes are provided at no cost and may be considered beneficial to know their current eye condition.
The risk of participating will be similar to those of normal spectacle lens wear, such as blurred vision, headache or discomfort due to spectacle frame fit. If participants experience any of these, they should let the investigator know.
Where is the study run from?
Zhongshan Ophthalmic Center of Sun Yat-Sen University (China)
When is the study starting and how long is it expected to run for?
November 2022 to September 2023
Who is funding the study?
SightGlass Vision, Inc (USA)
Who is the main contact?
Dr Lucill Wang (Sponsor), lwang@sightglassvision.com
Dr Xiang Chen (Study Investigator), chenxiang@gzzoc.com
Contact information
Principal Investigator
Zhongshan Ophthalmic Center of Sun Yat-sen University
Guangzhou
510060
China
 ORCID ID |
0000-0002-9551-9408 |
|---|---|
| Phone | +86 20-66610720 |
| chenxiang@gzzoc.com |
Scientific
4970 El Camino Real, Suite 100
Los Altos
94022
United States of America
| Phone | +1-707-530-2523 |
|---|---|
| lwang@sightglassvision.com |
Study information
| Study design | Single-center randomized double blind controlled three-test arm cross over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Observational Study on visual performance of three different myopia control optical lenses for children in China |
| Study acronym | CEDAR-2 |
| Study hypothesis | Myopia control spectacle lenses visual performance tested will be equivalent. |
| Ethics approval(s) | Approved 29/01/2023, Zhongshan Ophthalmic Center of Sun Yat-sen University Ethics Committee (54 Xianlie Nan Road, Guangzhou, Guangdong Providence, P.R. China; +86 20-66610720; zocethics@163.com), ref: 2023KYPJ002 |
| Condition | Myopia control in myopic children |
| Intervention | The purpose of this study is to compare the ‘visual performance’ of the three myopia control spectacle lenses (DOT, DIMS, CARE) and their habitual single vision spectacles. Participants will use all three spectacle lenses matching their prescriptions in a randomized sequence (computer generated). Each spectacle will be worn for 1 to 2 weeks. Measurements at baseline with their habitual spectacle and follow up visits with each myopia control spectacle will include visual acuity, reading speed, near contrast sensitivity, halometry and subjective questionnaires. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Diffusion Optics Technology (DOT), Defocus Incorporated Multiple Segments (DIMS), Cylindrical Annular Refractive Element (CARE). |
| Primary outcome measure | Visual performance measured using Aston Vision iPad App (visual acuity, reading speed, near contrast sensitivity, and halometry) of test spectacles at baseline and after 1-2 weeks of wear in comparison with habitual spectacles. 1. Visual acuity in logMAR (number of letters read on the letter chart) 2. Reading speed in maximum words per minute 3. Near contrast sensitivity at @ 1.5, 3.0, 6.0, 12.0 and 18.0 cycles per degree (cpd) 4. Halometry in halo radius in degrees |
| Secondary outcome measures | Visual performance measured using Aston Vision iPad App at baseline and after 1-2 weeks of wear with 3 different test spectacles: 1. Visual acuity in logMAR (number of letters read on the letter chart) 2. Reading speed in maximum words per minute 3. Near contrast sensitivity at @ 1.5, 3.0, 6.0, 12.0 and 18.0 cycles per degree (cpd) 4. Halometry in halo radius in degrees |
| Overall study start date | 10/11/2022 |
| Overall study end date | 01/09/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 48 |
| Participant inclusion criteria | 1. Myopic children aged 6 to 14 years, with spherical equivalent refraction (SER) -0.75 D to -4.00 D (by cycloplegic autorefraction) in each eye. 2. Best corrected visual acuity (BCVA) by manifest refraction of +0.10 logMAR (0.8 Snellen equivalent) or better in each eye. 3. Pass stereopsis and color vision screening. 4. Ability to comply with all study procedures, including assessments of visual performance with assigned correction. 5. Willingness to wear assigned spectacles for the duration of the study. 6. The subject's parent(s) or legal guardian(s) must read, understand and sign the ICF and receive a fully executed copy. |
| Participant exclusion criteria | 1. Prior use of any myopia control approaches, such as atropine, multifocal contact lenses, orthokeratology (ortho-K), or other spectacle lenses designed for myopia control including peripheral defocus, bifocal, and progressive addition lenses. 2. Astigmatism worse than -1.25 DC (by manifest refraction) in either eye. 3. Anisometropia (SER manifest refraction) greater than 1.00 D. 4. Amblyopia in either eye. 5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction. 6. Any ocular or systemic conditions that could influence refractive development or status [e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness). 7. Participation in any investigational clinical study within 30 days of the Screening visit. |
| Recruitment start date | 01/04/2023 |
| Recruitment end date | 15/06/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Guangzhou
510060
China
Sponsor information
Industry
13555 N. Stemmons Fwy
Rm 342
Dallas
TX 75234
United States of America
| Phone | +1-707-530-2523 |
|---|---|
| sfranz@sightglassvision.com | |
| Website | https://www.sightglassvision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 05/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication, Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal Added 16/07/2024: Presented the results of this study at the NCC conference in March 2024. Abstract attached. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 16/07/2024 | No | No |
Additional files
Editorial Notes
16/07/2024: The following changes were made to the study record:
1. Abstract uploaded.
2. Publication and dissemination plan, IPD sharing plan and sponsor details updated.
3. The intention to publish date was changed from 05/01/2024 to 05/01/2025.
08/09/2023: The following changes have been made:
1. The overall study end date has been changed from 30/09/2023 to 01/09/2023.
2. The total final enrolment number was added.
08/06/2023: Trial's existence confirmed by Zhongshan Ophthalmic Center of Sun Yat-sen University Ethics Committee.
