Contrast sensitivity evaluation of DOT spectacle lenses
| ISRCTN | ISRCTN16801917 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16801917 |
| Secondary identifying numbers | SGV_IU 01 |
- Submission date
- 02/01/2023
- Registration date
- 04/01/2023
- Last edited
- 16/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Novel spectacle Diffusion Optic Technology (DOT) lenses from SightGlass Vision (SGV) have shown the ability to control the progression of myopia in children. These lenses contain contrast-reducing segments in the peripheral area of the lens as a signal to halt eye growth. The purpose of this non-dispensing vision study is to compare the contrast sensitivity (the ability to see low contrast images), of adult subjects wearing 2 DOT spectacle lenses compared to clear single vision spectacle lenses and +0.50DS single vision spectacle lenses.
Who can participate?
Adults aged 18 years and older who have healthy eyes
What does the study involve?
This study involves one visit lasting approximately 4 hours or 2 visits lasting 2 hours each. Each participant will be reading letter charts from a distance while seeing through the different study spectacles in a randomized order.
What are the possible benefits and risks of participating?
You will not personally benefit from your participation, other than having your eyes examined. Even if there is no personal benefit to you, information from this research will provide insight into current and future product development aimed at improving spectacle lenses. Spectacle lenses are classified as a non-significant risk device. The lenses have a CE mark and are commercially available outside the USA. Due to the nature (non-dispensing, vision testing) and the short duration of the study, the risks of participating are minimal.
Where is the study run from?
Indiana University – School of Optometry, Bloomington (USA)
When is the study starting and how long is it expected to run for?
June 2022 to January 2023
Who is funding the study?
SightGlassVision (USA)
Who is the main contact?
Sylvie Franz, sfranz@sightglassvision.com (USA)
Contact information
Principal Investigator
Indiana University - School of Optometry
800 E Atwater Ave
Bloomington
IN 47405
United States of America
 ORCID ID |
0000-0001-9568-2064 |
|---|---|
| Phone | +1 812-856-0108 |
| kollbaum@indiana.edu |
Scientific
Indiana University - School of Optometry
800 E Atwater Ave
Bloomington
IN 47405
United States of America
| ORCID ID |
0000-0002-5157-2557 |
|---|---|
| Phone | +1 812-855-0559 |
| meyerd@indiana.edu |
Study information
| Study design | Prospective randomized controlled subject-masked single- and multiple-day repeated measure study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Contrast sensitivity evaluation of Diffusion Optics Technology (DOT) spectacle lenses |
| Study objectives | Contrast sensitivity measurements of the subjects wearing DOT spectacle lenses will be comparable to control (single vision and single vision +0.50DS). |
| Ethics approval(s) | Approved 28/07/2022, Sterling IRB (6300 Powers Ferry Road, Suite 600-351, Atlanta, GA 30339, USA; +1 770-690-9491; account_relations@sterlingirb.com), ref: 10203 |
| Health condition(s) or problem(s) studied | Myopia management using contrast management spectacle lenses |
| Intervention | Novel spectacle Diffusion Optic Technology (DOT) lenses from SightGlass Vision (SGV) have shown the ability to control the progression of myopia in children. These lenses contain contrast-reducing segments in the peripheral area of the lens as a signal to halt eye growth. This study investigates the contrast sensitivity measurements with DOT spectacle lenses compared with control SingleVision (SV) and SV +0.50DS. This study is a non-dispensing, cross-over design so all participants will see through all spectacle lenses tested. The order of the spectacle lenses will be randomized in the repeated measures experimental design. FrACT contrast sensitivity (CS) threshold at a 4m distance will be measured at 3, 6, 12 and 18 cycles per degree (cpd) while subjects view through the central and a peripheral portion (>4.5mm temporal of lens center) of all the spectacle lenses. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III/IV |
| Drug / device / biological / vaccine name(s) | Diffusion Optic Technology (DOT) spectacle lenses |
| Primary outcome measure | Contrast sensitivity measured using the FrACT test at a 4m distance at 8, 12, 6 and 3 cycles per degree under photopic (85cd/m2) conditions with each spectacle lens at one timepoint |
| Secondary outcome measures | Visual acuities measured using a standard letter chart at a 4m distance under photopic (85cd/m2) conditions with each spectacle lens at one timepoint |
| Overall study start date | 28/06/2022 |
| Completion date | 05/01/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 15 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Has had a self-reported oculo-visual examination in the last two years 2. Is at least 18 years of age and has full legal capacity to volunteer 3. Has read and understood the informed consent letter 4. Is willing and able to follow instructions and maintain the appointment schedule 5. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected 6. Is willing and able to wear contact lenses in the office for testing 7. Spectacle cylinder less than -0.75DC 8. Has clear corneas and no active ocular disease 9. Can tolerate having one eye covered and study procedures |
| Key exclusion criteria | 1. Has any systemic disease affecting their ocular health 2. Is using any systemic or topical medications that will affect their ocular health 3. Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect clear vision when wearing spectacle lenses 4. Is aphakic |
| Date of first enrolment | 01/08/2022 |
| Date of final enrolment | 31/10/2022 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Bloomington
IN 47405
United States of America
Sponsor information
Industry
4970 El Camino Real
Suite 100
Los Altos
CA 94022
United States of America
| Phone | +1 (949) 228 5416 |
|---|---|
| sfranz@sightglassvision.com | |
| Website | http://www.sightglassvision.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be published as a supplements to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 23/04/2023 | 16/02/2024 | No | No |
Editorial Notes
16/02/2024: An abstract of results was added.
14/06/2023: The overall study end date was changed from 31/12/2022 to 05/01/2023 and the plain English summary was updated accordingly.
16/02/2023: The study setting has been changed from ‘Other’.
04/01/2023: Trial's existence confirmed by Stirling institutional review board (IRB).
