Stellest Lens Wear in Adult Progressing Myopes
- Conditions
- Myopia, Progressive
- Interventions
- Device: Essilor® Stellest® spectacle lensDevice: Single-vision spectacle lens
- Registration Number
- NCT06520124
- Lead Sponsor
- University of Ulster
- Brief 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. 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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
- Previous myopia management (other than standard spectacle or contact lens correction)
- Ocular and systemic diseases which might affect visual performance or myopia development
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A1: Stellest lens wear in front of dominant eye Essilor® Stellest® spectacle lens Stellest lens wear in front of dominant eye. B1: Stellest lens wear in front of non-dominant eye Essilor® Stellest® spectacle lens Single vision lens wear in front of non-dominant eye A2: Single vision lens wear in front of non-dominant eye Single-vision spectacle lens Single vision lens wear in front of non-dominant eye. B2: Single-vision lens wear in front of dominant eye. Single-vision spectacle lens Single vision lens wear in front of dominant eye.
- Primary Outcome Measures
Name Time Method Change in axial length (mm) 2 years Change in axial length (mm) of the eye wearing the Stellest lens compared to the control eye wearing standard single vision lenses.
Change in cycloplegic autorefraction (D) 2 years Change in cycloplegic autorefraction (D) of the eye wearing the Stellest lens compared to the control eye wearing standard single vision lenses.
- Secondary Outcome Measures
Name Time Method Acceptability to adult patients of Stellest lenses prescribed for both eyes, assessed using the Stellest adult tolerability questionnaire. 1 month Acceptability to adult patients of the Stellest lens when prescribed for both eyes following the 2-year trial period.
Trial Locations
- Locations (1)
Ulster University
🇬🇧Coleraine, County Londonderry, United Kingdom