Stellest Lens Wear in Adult Progressing Myopes

NCT06520124 | Active Not Recruiting

• 1 other identifier: FCBMS-24-022
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia, Progressive

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 years

Secondary Outcomes (1)

• Acceptability to adult patients of Stellest lenses prescribed for both eyes, assessed using the Stellest adult tolerability questionnaire.

  1 month

Study Arms (4)

A1: Stellest lens wear in front of dominant eye

EXPERIMENTAL

Stellest lens wear in front of dominant eye.

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.

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

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.

Device: Single-vision spectacle lens

Interventions

Essilor® Stellest® spectacle lens DEVICE

Spectacle lens with highly aspherical lenslets.

Also known as: Highly Aspherical Lenslets, HAL, Stellest, Essilor Stellest, HALT

A1: Stellest lens wear in front of dominant eye; B1: Stellest lens wear in front of non-dominant eye

Single-vision spectacle lens DEVICE

Standard single-vision distance spectacle lens.

Also known as: Single-vision lens, single vision lens

A2: Single vision lens wear in front of non-dominant eye; B2: Single-vision lens wear in front of dominant eye.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Essilor International: collaborator
• University of Ulster: lead

Study Sites (1)

Ulster University

Coleraine, County Londonderry, BT52 1SA, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 26783753 BACKGROUND

• 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.

  PMID: 16909085 BACKGROUND

• 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.

  PMID: 24674576 BACKGROUND

• 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.

  PMID: 34989764 BACKGROUND

• 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.

  PMID: 22772022 BACKGROUND

• 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.

  PMID: 21276616 BACKGROUND

• 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.

  PMID: 32938970 BACKGROUND

• 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.

  PMID: 35357402 BACKGROUND

MeSH Terms

Conditions

Myopia, Degenerative; Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Sara J McCullough, PhD

  Ulster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not possible to mask as participant and/or investigator could identify which lens is 'different' from single-vision through visual inspection.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 25, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)