Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520124
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Stellest Lens Wear in Adult Progressing Myopes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Essilor Stellest Lenses in Slowing Down Myopia Progression in Young Adults
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWAP
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 -100D 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None