Spectacle Wear Support for Astigmatism

(SPEC Trial)

Overseen By Erin M Harvey, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Strabismus, Cataract, Epilepsy, Down Syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1155

Duration: Up to 30 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how wearing glasses full-time versus as-needed affects the development of young children with astigmatism, a condition where the eye doesn't focus light evenly, causing blurry vision. Participants will wear glasses either during all waking hours or as much as they accept. This trial is ideal for children with astigmatism in both eyes who haven't worn glasses or received vision therapy before. The goal is to determine which approach supports better developmental outcomes. As an unphased trial, this study offers a unique opportunity to contribute to understanding the best practices for managing astigmatism in children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It seems focused on eye conditions and spectacle wear, so it might not require changes to other medications.

What prior data suggests that spectacle wear support is safe for young children with astigmatism?

Research has shown that wearing glasses is generally safe for children. Studies have found that glasses can enhance a child's overall well-being, including mental and emotional health. Wearing glasses themselves has no known harmful side effects.

However, issues such as scratched or broken lenses might occur. While these problems can be annoying, they do not harm the child's health. Overall, wearing glasses is safe and well-tolerated for children with astigmatism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Spectacle Wear Support for Astigmatism trial because it explores how different strategies for encouraging children to wear glasses can impact their vision correction. Unlike traditional methods that often just prescribe glasses, this trial investigates two distinct approaches: full-time wear with strong parental support and ad-lib wear with minimal guidance. The focus is on understanding how consistent encouragement and support can make a difference in adherence and effectiveness, potentially offering new insights into managing astigmatism in children more effectively.

What evidence suggests that spectacle wear support is effective for astigmatism?

Studies have shown that wearing glasses can help children with astigmatism develop better. Research indicates that regularly wearing glasses can boost their learning and thinking skills. In this trial, one group of children will be encouraged to wear their glasses full-time, following the recommended schedule, with up to 89% adhering over time. Another group will wear glasses as they feel comfortable, benefiting in a less structured way. Both approaches in this trial aim to correct vision problems, potentially improving the overall quality of life for these young children. ^{6 7 8 9 10}

Who Is on the Research Team?

Erin M Harvey, Ph.D.

Principal Investigator

University of Arizona

John D Twelker, O.D., Ph.D.

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for young children aged 12 to 35 months with significant astigmatism in both eyes. Parents must consent, be willing to follow the study's protocol including regular visits and use of a sensor on glasses, speak English or Spanish, and plan to stay in Tucson until their child is about 3.5 years old. Children with strabismus, eye pathology, allergy to dilating drops, extreme prematurity, certain developmental conditions or previous vision treatments are excluded.

Inclusion Criteria

Parent/guardian provision of signed and dated informed consent form for Baseline/Eligibility Examination

Completion of Baseline/Eligibility Examination with cycloplegia

I agree to bring my child for study visits every 6 months, report on their glasses use, and let them wear a TheraMon® sensor.

Exclusion Criteria

I have been diagnosed with an eye condition (like cataracts or age-related macular degeneration).

Current or previous diagnosis of developmental or neurological conditions (per parent report and per medical record): H90.5 Congenital Deafness, and related disorders of hearing loss. G40.909 Epilepsy or other seizure disorder. P07.34 Prematurity 31 weeks, and other prematurity less than 32 weeks. P91.6 Hypoxic Ischemic Encephalopathy Q90.9 Down Syndrome, and other congenital syndromes associated with developmental delay. Q04.4 Septo-Optic Dysplasia Q91-Q92 Trisomy Other (13, 18, partial, complete, unbalanced translocations, mosaicism, duplications) R62.50 Developmental Delay, and related disorders exhibiting a delay in one or more streams of development (e.g. language, fine motor, gross motor, social)

You have had an allergic reaction to eye drops used to dilate your eyes in the past, causing redness and swelling.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are provided spectacles for either Full-Time wear or Ad Lib wear, with support and encouragement provided to maximize spectacle wear

Up to 30 months

Regular follow-ups with study staff for support and encouragement

Developmental and Visual Assessment

Assessment of cognitive, language, motor, social-emotional, and adaptive behavior development, as well as visual acuity

1 visit

In-person assessment when the child is age 1155-1275 days

Follow-up

Participants are monitored for developmental outcomes and visual acuity after the treatment phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spectacles
• Spectacle wear support

Trial Overview The study aims to see if wearing glasses full-time versus as tolerated (Ad Lib) affects development in toddlers with astigmatism. It involves providing spectacles and support for wear adherence while monitoring through scheduled visits every six months and using a TheraMon® sensor attached to the spectacle headband.

How Is the Trial Designed?

Group I: Full-Time Spectacle Wear Active Control 2 Interventions

Parents are asked to encourage their child to wear the spectacles full-time (all waking hours). A study staff member works closely with families throughout the child's participation to provide support and encouragement and to make suggestions on methods parents can use to maximize spectacle wear.

Group II: Ad-Lib Spectacle Wear Active Control 1 Intervention

Parents are asked to encourage their child to wear the spectacles as much as possible for the initial 30 days after dispensing, and thereafter to continue to offer the spectacles to the child but not force the child to wear them if they resist or refuse. Limited support for parents is provided with regard to maximizing spectacle wear.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Citations

1. withpower.com withpower.com/trial/phase-astigmatism-2-2021-43ecf

Spectacle Wear Support for Astigmatism (SPEC Trial) The purpose of this study is to compare developmental outcome for young children (12 to 35 months of age) with astigmatism meeting American Academy of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10436410/

The impact of spectacle correction on the well-being of ... Evidence suggests that spectacle correction improves children's cognitive and educational well-being, psychological well-being, mental health, and quality of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10036364/

Implementing interventions to promote spectacle wearing ... The combination of providing free spectacles along with educational interventions can lead to high levels of compliance among the study participants.

4. news.arizona.edu news.arizona.edu/news/study-looks-measure-benefits-eyeglasses-toddlers

Study Looks to Measure Benefits of Eyeglasses for Toddlers A team of University of Arizona researchers has received a five-year, $4.1 million grant to study whether using eyeglasses to correct astigmatism in toddlers ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Eyeglasses%22

San Mateo Clinical Trials The adaptive eyeglasses used in these tests do not fix any of the internal eye problems. They just compensate externally for the loss of the eye focusing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2880380/

Challenges, Attitudes and Practices of the Spectacle ... The wearers' challenges included expensive spectacles (43.0%), falling/scratched/broken lenses (29.4%) and fear that spectacles would damage the eyes (23.8%).

7. reviewofmm.com reviewofmm.com/sightglass-visions-18-month-data/

SightGlass Vision's 18-Month Data on DOT Spectacles ... Building on earlier 12-month results, which showed that SightGlass Vision's DOT 0.2 can slow average myopia progression by up to 75% after 12 ...

8. myopiaprofile.com myopiaprofile.com/articles/CARE-spectacles-myopia-control-one-year

CARE myopia control spectacle lenses: one year data Two designs of CARE lenses reduced myopia progression by just under 50% after one year, with only around 15% progressing more than 0.75D.

9. cureus.com cureus.com/articles/223376-non-compliance-of-spectacle-wear-in-school-going-children-with-refractive-errors.pdf

Non-compliance of Spectacle Wear in School Common indications for wearing spectacles include myopia, hypermetropia, astigmatism, and frequent headaches, which get worse on concentrating ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0161642019318792

A Randomized Noninferiority Trial of Wearing Adjustable ... Mean wear proportion of adjustable glasses was significantly lower than for standard glasses (45% vs. 58%; P = 0.01), although the adjusted ...