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Spectacle Wear Support for Astigmatism (SPEC Trial)
N/A
Recruiting
Led By John D Twelker, O.D., Ph.D.
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of dispensing of the first pair of spectacles at the spectacle prescription verification visit through the date of the developmental and visual assessment visit, up to 30 months.
Awards & highlights
SPEC Trial Summary
This trial will compare the outcomes of two groups of children with astigmatism: those who are encouraged to wear glasses full-time, and those whose parents decide when they wear glasses.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While there may not be direct side effects from wearing spectacles themselves, potential issues could include discomfort from wearing glasses regularly or skin irritation where the TheraMon® sensor contacts the head.
SPEC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the date of dispensing of the first pair of spectacles at the spectacle prescription verification visit through the date of the developmental and visual assessment visit, up to 30 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of dispensing of the first pair of spectacles at the spectacle prescription verification visit through the date of the developmental and visual assessment visit, up to 30 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cognitive Development
Secondary outcome measures
Adaptive Behavior
Language Development
Motor Development
+2 moreOther outcome measures
Duration of spectacle wear
SPEC Trial Design
2Treatment groups
Active Control
Group I: Full-Time Spectacle WearActive Control2 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 WearActive Control1 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.
Find a Location
Who is running the clinical trial?
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,185 Total Patients Enrolled
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,840 Total Patients Enrolled
John D Twelker, O.D., Ph.D.Principal InvestigatorUniversity of Arizona
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an eye condition (like cataracts or age-related macular degeneration).I agree to bring my child for study visits every 6 months, report on their glasses use, and let them wear a TheraMon® sensor.My guardian agrees to any group assignment in the study.You have had an allergic reaction to eye drops used to dilate your eyes in the past, causing redness and swelling.I have been diagnosed with strabismus recently.My family and I primarily speak English or Spanish.I have had treatments or worn glasses for lazy eye.I have been diagnosed with an eye condition like cataract, strabismus, or glaucoma.
Research Study Groups:
This trial has the following groups:- Group 1: Full-Time Spectacle Wear
- Group 2: Ad-Lib Spectacle Wear
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any qualifications that would enable me to partake in this test?
"To be eligible for this research trial, participants must have a valid prescription and fall in between the ages of one year old to almost 3 years old. Currently, 172 subjects are needed."
Answered by AI
What is the maximum number of individuals taking part in this research?
"Affirmative. Clinicaltrials.gov has evidence that this medical study, which was initially published on March 26th 2021, is recruiting patients actively. A total of 172 individuals are needed from a single clinic site."
Answered by AI
Is this research endeavor seeking new participants?
"Affirmative, information hosted on clinicaltrials.gov indicates that this medical research is still in search of participants. This trial was first uploaded to the web on March 26th 2021 and has since been updated as recent as March 28th 2022. 172 people are needed for the study at a single site."
Answered by AI
Are individuals aged 50 and above being accepted for the trial?
"This research initiative has outlined requirements for potential participants. Eligible candidates are between 1 year and 3 years old, while there are separate trials available to those under 18 or over 65."
Answered by AI
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