Stellest Lens Wear in Adult Progressing Myopes (SWAP)

February 17, 2026 updated by: University of Ulster

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • County Londonderry
      • Coleraine, County Londonderry, United Kingdom, BT52 1SA
        • Ulster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1: Stellest lens wear in front of dominant eye
Stellest lens wear in front of dominant eye.
Device: Essilor® Stellest® spectacle lens
Spectacle lens with highly aspherical lenslets.
Other Names:
  • HAL
  • Highly Aspherical Lenslets
  • Stellest
  • Essilor Stellest
  • HALT
Placebo Comparator: A2: Single vision lens wear in front of non-dominant eye
Single vision lens wear in front of non-dominant eye.
Device: Single-vision spectacle lens
Standard single-vision distance spectacle lens.
Other Names:
  • Single-vision lens
  • single vision lens
Experimental: B1: Stellest lens wear in front of non-dominant eye
Single vision lens wear in front of non-dominant eye
Device: Essilor® Stellest® spectacle lens
Spectacle lens with highly aspherical lenslets.
Other Names:
  • HAL
  • Highly Aspherical Lenslets
  • Stellest
  • Essilor Stellest
  • HALT
Placebo Comparator: B2: Single-vision lens wear in front of dominant eye.
Single vision lens wear in front of dominant eye.
Device: Single-vision spectacle lens
Standard single-vision distance spectacle lens.
Other Names:
  • Single-vision lens
  • single vision lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in axial length (mm)
Time Frame: 2 years
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)
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability to adult patients of Stellest lenses prescribed for both eyes, assessed using the Stellest adult tolerability questionnaire.
Time Frame: 1 month
Acceptability to adult patients of the Stellest lens when prescribed for both eyes following the 2-year trial period.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulster

Collaborators

Essilor International

Investigators

  • Principal Investigator: Sara J McCullough, PhD, Ulster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2024

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCBMS-24-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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