Myopia, ProgressiveSWAPNCT06520124
Stellest Lens Wear in Adult Progressing Myopes
A study testing Essilor® Stellest® spectacle lens and Single-vision spectacle lens in people with Myopia, Progressive, run by University of Ulster at 1 site in United Kingdom.
Trial summary
It is expected that myopia progression stabilises in the late teenage years, however, some studies report that myopia progression continues through early adulthood in as many as one third of myopes. Similarly, there are reports of myopia commencing in early adulthood. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Essilor® Stellest® spectacle lens and Single-vision spectacle lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2024to 30 Dec 2027
- Phase
- Interventional
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cycloplegic SER less than -0.75D
- Astigmatism of 1.50D or less
- Anisometropia of 1.50D or less
- Evidence of annual progression of myopia of at least 0.50D in the previous two-year period
Who cannot join
- Previous myopia management (other than standard spectacle or contact lens correction)
- Ocular and systemic diseases which might affect visual performance or myopia development
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ulster University
Coleraine, County Londonderry, BT52 1SA
About this study
Official title: Effectiveness of Essilor® Stellest® Lenses in Slowing Down Myopia Progression in Young Adults
It is expected that myopia progression stabilises in the late teenage years, however, some studies report that myopia progression continues through early adulthood in as many as one third of myopes. Similarly, there are reports of myopia commencing in early adulthood. Although the rate of progression is slower than that occurring in childhood, between 20-35% of adults aged between 20-30 years were reported to progress by at least -1.00D over a five year period. Given that every dioptre increase in myopia results in an increased overall lifetime risk of serious ocular pathology, it seems opportune to investigate whether myopia management treatments designed to slow myopia progression in childhood could be beneficial for progressing adult myopes. The proposed study will conduct a prospective, randomised, paired-eye, trial with cross-over to evaluate the efficacy of Essilor Stellest myopia management spectacle lenses on the progression of myopia in adults aged between 18-40 years. The outcomes from the trial will provide novel evidence regarding the utility of these lenses in an adult population.
Read the detailed description
This is a 2-year, prospective, randomised, paired-eye controlled trial with cross-over which will be conducted at Ulster University, Coleraine, Northern Ireland. The trial will evaluate the efficacy of Essilor Stellest myopia management spectacle lenses on the progression of myopia in adults aged between 18-40 years. Participants will act as their own control, wearing a Stellest lens in front of one eye and a single vision lens in front of the fellow eye. At the 12-month visit, lens allocation will be crossed-over between eyes and worn for a further 12 months. Randomisation of whether Stellest will be worn in the dominant or non-dominant eye first will be conducted using permuted block design.
Participants will be asked to wear the study spectacles for at least 12 hours per day, 6 days per week. No other form of myopia management spectacle or contact lens will be worn during the trial period. At the two-year review participants will be given the option of continuing with Stellest lenses in both eyes or reverting to single vision spectacles in both eyes depending on the results of the study. Those participants who continue to wear Stellest lenses (binocularly) will be contacted after one month to investigate the acceptability of Stellest wear in adult myopes.
Participants will be screened at baseline to ensure they meet the inclusion criteria. Participants will be asked if they have ever attended the hospital eye service or have been told they have an eye condition by their optometrists. Fundus images and slit lamp examination will also be conducted at baseline to confirm eye health. Cycloplegic refraction and axial length will be measured at baseline, 6-months and 12-months using the Shin-Nippon NVision-K 5001 and IOLMaster 700 respectively. Cycloplegia will be induced by two drops of 1% tropicamide separated by 5 minutes. Punctal occlusion following instillation of the drop will be applied to reduce systemic absorption.
At 12-months, the crossover will take place. A further assessment of cycloplegic refraction and axial length will be performed 6-months (18-month visit) and 12-months (24-month visit) after the crossover. The following additional measurements will also be made to inform parameters that are associated with better response to treatment and to ensure visual function remains adequate while wearing the study spectacles. These measurements will be taken at baseline and crossover.
- Near and distance visual acuity will be measured using a crowded logMAR letter chart at 33cm and 3m
- Accommodative function will be assessed using dynamic retinoscopy using the UC-Cube
- Binocularity will be assessed using distance and near prism cover test
- Field of vision will be assessed using a Humphrey suprathreshold screening test
- Peripheral refraction will be measured at 30 degrees nasally and temporally
- Choroidal thickness will be measured using a six radial scan using the Heidelberg Spectralis
- Visual comfort will be surveyed by telephone one week after collection of the study spectacles to ensure participants are tolerating the paired-eye control condition
- Conditions
- Myopia, Progressive
- Being tested
- Essilor® Stellest® spectacle lens, Single-vision spectacle lens
- Keywords
- Adult myopia, Progressing adult myopes, Stellest, HAL, Progressive myopia, Myopia, Refractive error, Axial length
- Medical subject headings
- Myopia, Degenerative, Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essilor® Stellest® spectacle lensDevice
Also called Highly Aspherical Lenslets, HAL, Stellest, Essilor Stellest
Spectacle lens with highly aspherical lenslets.
Single-vision spectacle lensDevice
Also called Single-vision lens, single vision lens
Standard single-vision distance spectacle lens.
| Study group | Role | What they receive |
|---|---|---|
| A1: Stellest lens wear in front of dominant eye | Experimental | Stellest lens wear in front of dominant eye. Receives: Device: Essilor® Stellest® spectacle lens |
| A2: Single vision lens wear in front of non-dominant eye | Placebo comparator | Single vision lens wear in front of non-dominant eye. Receives: Device: Single-vision spectacle lens |
| B1: Stellest lens wear in front of non-dominant eye | Experimental | Single vision lens wear in front of non-dominant eye Receives: Device: Essilor® Stellest® spectacle lens |
| B2: Single-vision lens wear in front of dominant eye. | Placebo comparator | Single vision lens wear in front of dominant eye. Receives: Device: Single-vision spectacle lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in axial length (mm)
Change in axial length (mm) of the eye wearing the Stellest lens compared to the control eye wearing standard single vision lenses.
Measured: 2 years
Change in cycloplegic autorefraction (D)
Change in cycloplegic autorefraction (D) of the eye wearing the Stellest lens compared to the control eye wearing standard single vision lenses.
Measured: 2 years
Secondary outcomes (1)
Acceptability to adult patients of Stellest lenses prescribed for both eyes, assessed using the Stellest adult tolerability questionnaire.
Acceptability to adult patients of the Stellest lens when prescribed for both eyes following the 2-year trial period.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start17 Oct 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will wear the treatment lens in front of one eye and a single vision lens in front of the other eye (Arms A1 and A2). This will be randomised by eye dominancy and crossed-over after one year (Arms B1 and B2).
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Essilor International
- Responsible party
- Sponsor
- Investigators
- Sara J McCullough, PhD, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520124
- Sponsor's protocol ID
- FCBMS-24-022
- Acronym
- SWAP
- Status last verified
- Feb 2026
- First submitted
- 9 Jul 2024
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data.
Publications
McCullough SJ, O'Donoghue L, Saunders KJ. Six Year Refractive Change among White Children and Young Adults: Evidence for Significant Increase in Myopia among White UK Children. PLoS One. 2016 Jan 19;11(1):e0146332. doi: 10.1371/journal.pone.0146332. eCollection 2016.
PubMed 26783753Bullimore MA, Reuter KS, Jones LA, Mitchell GL, Zoz J, Rah MJ. The Study of Progression of Adult Nearsightedness (SPAN): design and baseline characteristics. Optom Vis Sci. 2006 Aug;83(8):594-604. doi: 10.1097/01.opx.0000230274.42843.28.
PubMed 16909085Parssinen O, Kauppinen M, Viljanen A. The progression of myopia from its onset at age 8-12 to adulthood and the influence of heredity and external factors on myopic progression. A 23-year follow-up study. Acta Ophthalmol. 2014 Dec;92(8):730-9. doi: 10.1111/aos.12387. Epub 2014 Mar 27.
PubMed 24674576Lee SS, Lingham G, Sanfilippo PG, Hammond CJ, Saw SM, Guggenheim JA, Yazar S, Mackey DA. Incidence and Progression of Myopia in Early Adulthood. JAMA Ophthalmol. 2022 Feb 1;140(2):162-169. doi: 10.1001/jamaophthalmol.2021.5067.
PubMed 34989764Flitcroft DI. The complex interactions of retinal, optical and environmental factors in myopia aetiology. Prog Retin Eye Res. 2012 Nov;31(6):622-60. doi: 10.1016/j.preteyeres.2012.06.004. Epub 2012 Jul 4.
PubMed 22772022Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26.
PubMed 21276616McCullough S, Adamson G, Breslin KMM, McClelland JF, Doyle L, Saunders KJ. Axial growth and refractive change in white European children and young adults: predictive factors for myopia. Sci Rep. 2020 Sep 16;10(1):15189. doi: 10.1038/s41598-020-72240-y.
PubMed 32938970Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401.
PubMed 35357402