Astigmatism BilateralSPECNCT04728451
Spectacle Prescribing in Early Childhood
A study testing Spectacle wear support and Spectacles in people with Astigmatism Bilateral and Eyeglasses, run by University of Arizona at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism Bilateral, Eyeglasses
- What is being tested?
- Spectacle wear support and Spectacles
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2021to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parent/guardian provision of signed and dated informed consent form for Baseline/Eligibility Examination.
- Completion of Baseline/Eligibility Examination with cycloplegia.
- Bilateral astigmatism: Astigmatism ≥2.25D in the most astigmatic eye and ≥1.75D in the fellow eye based on manual cycloplegic retinoscopy conducted at Baseline/Eligibility Examination.
- Parent/guardian willing to accept assignment to either randomized group.
- Parent/guardian provision of signed and dated informed consent form for randomized SPEC Study.
- Parent willing to commit to study visits every 180 days, to be contacted (phone, email, or text) for reports of spectacle wear, and to allow their child to wear the TheraMon® sensor on the spectacle headband.
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- Child and Family are primarily English or Spanish speaking.
- Parent/guardian does not anticipate moving out of Tucson area prior to their child reaching age 1275 days (approximately age 3 ½ years).
- Parent/guardian has not enrolled another child in the SPEC trial.
Who cannot join
- Gestational age <32 weeks (per parent report).
- Anisometropia ≥1.50 D spherical equivalent per manual cycloplegic retinoscopy conducted at the Baseline/Eligibility Examination.
- Current manifest strabismus per Baseline/Eligibility Examination.
- Ocular pathology per Baseline/Eligibility Examination (H44* or H25* diagnosis code).
- Previously diagnosed manifest strabismus or other ocular abnormalities (per parent report and per medical record):
- H25* (Cataract)
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- H44* (Disorders of the Globe)
- H50* (Strabismus)
- H55* (Irregular Eye Movement and Nystagmus)
- Q15.0 (Congenital Glaucoma)
- Other diagnosis of an ocular abnormality
- Previous spectacle wear, amblyopia therapy, or vision therapy (per parent report and per medical record).
- H53* (Amblyopia)
- Other spectacle wear, amblyopia therapy, or vision therapy
- 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).
- Other diagnosis of a developmental or neurological condition
- History of allergic response to dilating eye drops (per parent report):
- Local redness and swelling of the eyelid consistent with contact dermatitis which resulted in the parent being informed that the child had a drug allergy to one of the dilating eye drops (proparacaine or cyclopentolate) or one of the carrier or preservative agents used in the formulation of these drops.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectacle Prescribing in Early Childhood (SPEC)
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).
Read the detailed description
The benefits and drawbacks of spectacle treatment for bilateral astigmatism in young children are not known. The SPEC study compares outcomes for young children (12 to < 35 months of age) with astigmatism meeting spectacle prescribing recommendations and randomized to either Full-Time spectacle wear (encouraged and reinforced) or Ad Lib spectacle wear (only as accepted by the child). The primary outcome analysis compares cognitive development at 38-42 months in children randomized to the Full-Time and Ad Lib groups. Secondary analyses compare Language, Motor, Social-Emotional, and Adaptive Behavior developmental outcomes and visual acuity outcome for children randomized to the Full-Time and Ad Lib groups.
- Conditions
- Astigmatism Bilateral, Eyeglasses
- Being tested
- Spectacle wear support, Spectacles
- Keywords
- Astigmatism, Infant, Child, Preschool, Cognitive Development, Motor Development, Language Development, Child Development, Visual Acuity
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectacle wear supportBehavioural
Parents of children in the full-time group are provided with encouragement, support, and counseling throughout the study in order to maximize their child's spectacle wear.
SpectaclesDevice
Children prescribed and provided spectacles with full correction of their refractive error, with the exception of prescriptions with ≥ +1.50D sphere (plus cylinder notation) in the least hyperopic eye, which will be symmetrically reduced by 1.00D
| Study group | Role | What they receive |
|---|---|---|
| Full-Time Spectacle Wear | Active comparator | 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. Receives: Behavioral: Spectacle wear support; Device: Spectacles |
| Ad-Lib Spectacle Wear | Active comparator | 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. Receives: Device: Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Development
Cognitive Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
Measured: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Secondary outcomes (5)
Language Development
Language Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
Measured: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Motor Development
Motor Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
Measured: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Social-Emotional Development
Social-Emotional Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
Measured: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Adaptive Behavior
Adaptive Behavior Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
Measured: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Visual Acuity
Binocular visual acuity tested using the Amblyopia Treatment Study HOTV Protocol. Child wears most recent prescription for testing (or no spectacles, if discontinued by study doctor). Tester is masked to the child's randomized group. Acuity is recorded and analyzed as log MAR values (continuous scale). A difference of 0.10 log MAR between randomized groups will be considered clinically meaningful.
Measured: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start25 Mar 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Astigmatism BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Dan Twelker, University of Arizona
- Investigators
- Erin M Harvey, Ph.D., Principal investigator, University of ArizonaJohn D Twelker, O.D., Ph.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728451
- Sponsor's protocol ID
- 1911187060
- Other IDs
- UG1EY029657
- Acronym
- SPEC
- Status last verified
- Dec 2024
- First submitted
- 21 Jan 2021
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. De-identified data will be available upon request after publication by contacting the study Principal Investigators.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectacle Prescribing in Early Childhood (SPEC)
- ClinicalTrials.gov ID
- NCT04728451
- Acronym / sponsor ID
- SPEC / 1911187060
- Conditions
- Astigmatism Bilateral, Eyeglasses
- Keywords
- Astigmatism, Infant, Child, Preschool, Cognitive Development, Motor Development, Language Development, Child Development, Visual Acuity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The benefits and drawbacks of spectacle treatment for bilateral astigmatism in young children are not known. The SPEC study compares outcomes for young children (12 to < 35 months of age) with astigmatism meeting spectacle prescribing recommendations and randomized to either Full-Time spectacle wear (encouraged and reinforced) or Ad Lib spectacle wear (only as accepted by the child). The primary outcome analysis compares cognitive development at 38-42 months in children randomized to the Full-Time and Ad Lib groups. Secondary analyses compare Language, Motor, Social-Emotional, and Adaptive Behavior developmental outcomes and visual acuity outcome for children randomized to the Full-Time and Ad Lib groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-Time Spectacle Wear | Active comparator | Behavioral: Spectacle wear support, Device: SpectaclesParents 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. |
| Ad-Lib Spectacle Wear | Active comparator | Device: SpectaclesParents 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 may qualify
- Ages
- 12 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Parent/guardian provision of signed and dated informed consent form for Baseline/Eligibility Examination.
- Completion of Baseline/Eligibility Examination with cycloplegia.
- Bilateral astigmatism: Astigmatism ≥2.25D in the most astigmatic eye and ≥1.75D in the fellow eye based on manual cycloplegic retinoscopy conducted at Baseline/Eligibility Examination.
- Parent/guardian willing to accept assignment to either randomized group.
- Parent/guardian provision of signed and dated informed consent form for randomized SPEC Study.
Key exclusion criteria (26 listed)
- Gestational age <32 weeks (per parent report).
- Anisometropia ≥1.50 D spherical equivalent per manual cycloplegic retinoscopy conducted at the Baseline/Eligibility Examination.
- Current manifest strabismus per Baseline/Eligibility Examination.
- Ocular pathology per Baseline/Eligibility Examination (H44* or H25* diagnosis code).
- Previously diagnosed manifest strabismus or other ocular abnormalities (per parent report and per medical record):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectacle wear supportParents of children in the full-time group are provided with encouragement, support, and counseling throughout the study in order to maximize their child's spectacle wear. | Behavioural | Full-Time Spectacle Wear |
| SpectaclesChildren prescribed and provided spectacles with full correction of their refractive error, with the exception of prescriptions with ≥ +1.50D sphere (plus cylinder notation) in the least hyperopic eye, which will be symmetrically reduced by 1.00D | Device | Ad-Lib Spectacle Wear, Full-Time Spectacle Wear |
Primary outcome
Cognitive Development
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Cognitive Scale Composite Score on the "Bayley Scales of Infant and Toddler Development, 3rd Edition". Tester is masked to the child's randomized group. Scores (continuous scale) are based on published age norms (mean =100, standard deviation = 15) and range from 40-160 with higher scores indicating better outcomes. A difference of ≥10 points between randomized groups will be considered clinically meaningful.
5 secondary outcomes
Language Development
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Motor Development
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Social-Emotional Development
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Adaptive Behavior
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Visual Acuity
Time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: Yes. This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. De-identified data will be available upon request after publication by contacting the study Principal Investigators.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin M Harvey, Ph.D. principal investigator
University of Arizona
John D Twelker, O.D., Ph.D. principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacle wear support and Spectacles in people with Astigmatism Bilateral and Eyeglasses, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Development (time frame: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.