MedDataX Logo

Stellest Lens Wear in Adult Progressing Myopes

NCT ID: NCT06520124

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia, Progressive

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Adult myopia Progressing adult myopes Stellest HAL Progressive myopia Myopia Refractive error Axial length

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Not possible to mask as participant and/or investigator could identify which lens is 'different' from single-vision through visual inspection.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A1: Stellest lens wear in front of dominant eye

Stellest lens wear in front of dominant eye.

Group Type EXPERIMENTAL

Essilor® Stellest® spectacle lens

Intervention Type DEVICE

Spectacle lens with highly aspherical lenslets.

A2: Single vision lens wear in front of non-dominant eye

Single vision lens wear in front of non-dominant eye.

Group Type PLACEBO_COMPARATOR

Single-vision spectacle lens

Intervention Type DEVICE

Standard single-vision distance spectacle lens.

B1: Stellest lens wear in front of non-dominant eye

Single vision lens wear in front of non-dominant eye

Group Type EXPERIMENTAL

Essilor® Stellest® spectacle lens

Intervention Type DEVICE

Spectacle lens with highly aspherical lenslets.

B2: Single-vision lens wear in front of dominant eye.

Single vision lens wear in front of dominant eye.

Group Type PLACEBO_COMPARATOR

Single-vision spectacle lens

Intervention Type DEVICE

Standard single-vision distance spectacle lens.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Essilor® Stellest® spectacle lens

Spectacle lens with highly aspherical lenslets.

Intervention Type DEVICE

Single-vision spectacle lens

Standard single-vision distance spectacle lens.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Highly Aspherical Lenslets HAL Stellest Essilor Stellest HALT Single-vision lens single vision lens

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Previous myopia management (other than standard spectacle or contact lens correction)
* Ocular and systemic diseases which might affect visual performance or myopia development
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Essilor International

INDUSTRY

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sara J McCullough, PhD

Role: PRINCIPAL_INVESTIGATOR

Ulster University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ulster University

Coleraine, County Londonderry, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sara J McCullough, PhD

Role: CONTACT

Phone: +442870123078

Email: [email protected]

Jane M Fulton, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sara J McCullough, PhD

Role: primary

Jane M Fulton, PhD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Stern E. Cytohistopathology of cervical cancer. Cancer Res. 1973 Jun;33(6):1368-78. No abstract available.

Reference Type BACKGROUND
PMID: 4718680 (View on PubMed)

Bullimore 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.

Reference Type BACKGROUND
PMID: 16909085 (View on PubMed)

Parssinen 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.

Reference Type BACKGROUND
PMID: 24674576 (View on PubMed)

Lee 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.

Reference Type BACKGROUND
PMID: 34989764 (View on PubMed)

Flitcroft 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.

Reference Type BACKGROUND
PMID: 22772022 (View on PubMed)

Anstice 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.

Reference Type BACKGROUND
PMID: 21276616 (View on PubMed)

McCullough 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.

Reference Type BACKGROUND
PMID: 32938970 (View on PubMed)

Bao 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.

Reference Type BACKGROUND
PMID: 35357402 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FCBMS-24-022

Identifier Type: -

Identifier Source: org_study_id