Novel Spectacle Lenses for Myopia
(EUCALYPTUS Trial)
Recruiting in Palo Alto (17 mi)
+13 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: SightGlass Vision, Inc.
Must not be taking: Atropine
Disqualifiers: Contact lenses, Bifocals, Amblyopia, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial is testing a treatment to see how well it works for younger children. The study will look at results over time to predict how effective the treatment will be in the long term. The trial involves multiple sites to ensure accurate results.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using any myopia control treatments like atropine, you would not be eligible to participate.
What data supports the effectiveness of the treatment using novel spectacle lenses for myopia?
Research shows that impact-resistant spectacle lenses, especially those made from plastic materials, are effective in preventing eye injuries during activities with a risk of impact. This suggests that the lenses used in the trial may offer protective benefits, although their specific effectiveness in slowing myopia progression is not directly addressed in the provided studies.
12345Are spectacle lenses generally safe for humans?
Spectacle lenses are generally safe, but there is a small risk of eye injuries, especially during sports or high-impact activities. Using impact-resistant materials like polycarbonate can reduce this risk, and it's important to be cautious if you have certain eye conditions or a history of eye surgery.
13678How do novel spectacle lenses for myopia differ from other treatments?
The novel spectacle lenses for myopia are unique because they are designed to be impact-resistant, which means they are less likely to break or shatter compared to regular lenses. This feature makes them particularly suitable for individuals who engage in activities with a higher risk of eye injury, providing both vision correction and enhanced safety.
1291011Eligibility Criteria
This trial is for children aged 6-8 with mild to moderate near-sightedness (myopia) who have good vision with glasses and no more than a small difference in prescription between their eyes. They must be able to wear the study glasses at least 10 hours a day, not use contact lenses, and have no eye conditions or systemic diseases affecting vision.Inclusion Criteria
Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye
You are willing to not wear contact lenses for the entire 24-month trial period.
The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form
+6 more
Exclusion Criteria
I currently use or have used bifocals or progressive glasses.
I have a 'lazy eye'.
You have a condition called strabismus, which means your eyes do not align properly.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive single vision, impact-resistant spectacle lenses
12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests if special spectacle lenses can control worsening myopia in young children compared to regular single-vision lenses. It's a masked study where neither participants nor observers know which type of lens each child gets, randomly assigning kids into two groups equally.
2Treatment groups
Experimental Treatment
Group I: Test Arm 2Experimental Treatment1 Intervention
Single vision, impact-resistant spectacle lenses
Group II: Test Arm 1Experimental Treatment1 Intervention
Single vision, impact-resistant spectacle lenses
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Paje OptometricSanta Ana, CA
New England College of OptometryBoston, MA
Elsa Pao, ODOakland, CA
Scripps Poway EyecareSan Diego, CA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
SightGlass Vision, Inc.Lead Sponsor
References
Spectacle-related eye injuries, spectacle-impact performance and eye protection. [2015]The aim was to review the prevalence of spectacle-related ocular trauma and the performance of currently available spectacle materials and to identify the risk factors associated with spectacle-related ocular trauma. A literature review was conducted using Medline, Embase and Google with the keywords 'eyeglasses' OR 'spectacles' AND 'ocular injury' / 'eye injury'/ 'eye trauma' / 'ocular trauma'. Articles published prior to 1975 were excluded from this review because of advances in spectacle lens technology and Food and Drug Administration legislative changes requiring impact resistance of all prescription spectacle lenses in the United States. Six hundred and ninety-five individual ocular traumas, for which spectacles contributed to or were the main cause of injury, were identified in the literature. Eye injuries occurred when spectacles were worn in sports, in which medium- to high-impact energies were exerted from balls, racquets or bats and/or as a result of a collision with another player. Frame, lens design and product material choice were found to be associated with ocular injury, with polycarbonate lenses cited as the material of choice in the literature. International, regional and national standards for spectacle lenses had a wide range of impact requirements for prescription spectacle lenses, sports eye protection and occupational eye protection. Spectacle-related injury represents a small but preventable cause of ocular injury. With the increasing numbers of spectacle wearers and calls to spend more time outdoors to reduce myopia, spectacle wearers need to be made aware of the potential risks associated with wearing spectacles during medium- to high-risk activities. At particular risk are those prone to falls, the functionally one-eyed, those who have corneal thinning or have had previous eye surgery or injury. With increased understanding of specific risk factors, performance guidelines can be developed for prescription spectacle eye-protection requirements.
Ballistic impact resistance of selected organic ophthalmic lenses. [2015]The aim was to assess the impact resistance of coated and uncoated mid-index spectacle lens materials using the ballistic impact test.
Material and thickness: the important factors in the impact resistance of spectacle lenses. [2016]The identify the population at risk of permanent visual impairment from injuries associated with spectacles, we analysed 446 cases of penetrating ocular injury occurring over a ten year period. Sixteen injuries (3.6%) were due to spectacles; 40% of these were adult male amateur athletes. We used the drop-ball test to determine the important factors in the resistance to impact of 177 used spectacle lenses (29 plastic C39, 40 heat-tempered glass, 108 non-tempered glass). We found that material and thickness were the most important. The plastic lenses were the most impact resistant and non-tempered glass lenses the least, with heat-tempered glass lenses falling between. Plastic lenses of adequate centre thickness mounted in plastic frames are recommended for all children and all adults involved in athletics.
Impact resistance: an overview. [2006]The basic concepts of impact resistance are reviewed. Also discussed are the research on materials, treatment and testing procedures, mechanisms of fracture and the factors affecting impact resistance. Research has shown that the strength of a lens treated or untreated is well below the theoretical strength of glass. The impact resistance of a lens is altered by the presence of breaks in the surface of a lens. The drop ball test as mandated by the FDA is essentially a control test. Its use as a means of evaluating the performance of a lens has been open to question. Researchers have suggested alternative forms of testing which may be more valid in assessing the impact resistance of an ophthalmic lens.
Spectacle Lenses With Highly Aspherical Lenslets for Slowing Myopia: A Randomized, Double-Blind, Cross-Over Clinical Trial: Parts of these data were presented as a poster at the Annual Research in Vision and Ophthalmology meeting, 2022. [2023]To evaluate myopia progression with highly aspherical lenslet (HAL) spectacles vs conventional single vision (SV) spectacles.
Statistical procedures for impact resistance testing at increased drop-ball heights. [2019]Impact resistance testing of prescription eyewear and nonprescription sunglasses is normally performed at a drop-ball height of 50 in (1.27 m). This paper presents a statistics-based testing method that uses increased drop-ball heights.
Effect of Ultraviolet Exposure on Impact Resistance of Ophthalmic Lenses. [2018]To investigate the effect of ultraviolet radiation (UVR) on the impact resistance of organic ophthalmic lens materials.
Prescription compliance in ophthalmic lenses. [2015]Tolerances required for ophthalmic lenses are set down in national and international standards. It appears that the compliance of manufactured lenses has not been reported previously. Assembling a statistical quantity of lenses of a single prescription is usually an expensive process. It was, secondary to a lens impact study, possible to assemble a large number of plano lenses. In the assessment of the fracture velocity of lenses approximately 20 plano lenses of each material and thickness are required. Prior to using lenses for the impact study, they were checked for prescription. The results of the prescription measurements are reported here and the results of the impact study are reported in a separate paper.
Shatter resistance of spectacle lenses. [2016]To evaluate the relative strength and shatter resistance of spectacle lenses currently used in sunglasses and dress, sports, and industrial eyewear.
Effect of multiple antireflection coatings on impact resistance of Hoya Phoenix spectacle lenses. [2015]To investigate how the impact resistance of Hoya Phoenix spectacle lenses is affected by centre thickness and the application of a multilayer antireflection (MAR) coating.
[Aspherical single-strength eyeglasses with improved wearing comfort]. [2009]A new plastic single-vision lens series is presented with an aspherically designed front surface for the weak to medium-strength positive power range. With this lens the asphere is used to improve the non-optical properties and, at the same time, to maintain an image quality comparable to the high standard offered by regular spectacle lenses. The various factors which determine the optimization of so-called comfort in wear are discussed in detail.