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

88 Participants Needed

Trial Summary

What is the purpose of this 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 Ophthalmology spectacle prescribing guidelines and who are prescribed and provided spectacles for either Full-Time wear (encouraged and reinforced) or Ad Lib wear (wear dependent on child acceptance).

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.

How does the Spectacle Wear Support for Astigmatism treatment differ from other treatments for astigmatism?

The Spectacle Wear Support for Astigmatism treatment is unique because it focuses on supporting and encouraging consistent spectacle wear, which is crucial for managing astigmatism effectively. Unlike other treatments that may involve surgical or corrective procedures, this approach emphasizes adherence to wearing spectacles, similar to how brace adherence is crucial in scoliosis treatment. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Spectacles, Spectacle wear support for Astigmatism?

The study on the impact of eyeglasses on vision-related quality of life shows that providing eyeglasses can improve vision-related quality of life, suggesting that wearing spectacles may help people with astigmatism see better and feel more comfortable. ^{6 7 8 9 10}

Research Team

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

Principal Investigator

University of Arizona

Erin M Harvey, Ph.D.

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of an accommodative support lens designed for computer users. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Refractive versus corneal changes after photorefracive keratectomy for astigmatism. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of eyeglasses on vision-related quality of life in American Indian/Alaska Natives. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Is Astigmatism Correction Necessary for Patients With Cataract Who Have Corneal Astigmatism of Less Than 0.75 D? [2023]

5. England pubmed.ncbi.nlm.nih.gov

The visual and functional impacts of astigmatism and its clinical management. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Postural stabilization by trunk tightening force generated by passive power-assist device. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Development of a model of interprofessional support interventions to enhance brace adherence in adolescents with idiopathic scoliosis: a qualitative study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Exploration of Contributory Factors to an Unpleasant Bracing Experience of Adolescent Idiopathic Scoliosis Patients a Quantitative and Qualitative Research. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Smart orthosis for the treatment of adolescent idiopathic scoliosis. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Idiopathic scoliosis and brace treatment: an innovative device to assess corrective pressure. [2021]