HyperopiaHTS1NCT01515475
Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation
A study testing Glasses in people with Hyperopia, run by Jaeb Center for Health Research at 2 sites in United States.
Trial summary
The purpose of this study is to compare visual acuity outcomes and development of strabismus after a 3-year follow-up period in children age 12 to <72 months with moderate hyperopia (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only after confirmation of pre-specified… Read more about this study
- Who is it for?
- Ages 12 to 71 months
- Conditions the study is for
- Hyperopia
- What is being tested?
- Glasses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Feb 2012to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 12 to < 72 months
- Refractive error between +3.00D and +6.00D SE (by cycloplegic refraction) in either eye
- Astigmatism < 1.50D in both eyes
- Spherical equivalent anisometropia ≤ +1.50D
- For children 36 to <72 months of age:
- No evidence of subnormal visual acuity - Uncorrected monocular visual acuity in both eyes of 20/50 or better for age 36 to <48 months,20/40 or better for age 48 to <60 months, and 20/32 or better for ages 60 to <72 months measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol
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- Zero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol
- Age-normal stereoacuity on the Randot Preschool Stereotest (see Table 2 of protocol)
- Gestational age >32 weeks
- Investigator is willing to prescribe glasses per protocol or observe the hyperopia untreated for 3 years unless specific criteria for deterioration outlined in section 3.3.3 are confirmed.
- Parent understands the protocol and is willing to accept randomization to either glasses or no glasses initially, and is willing to wear glasses as prescribed or accept that glasses will not be prescribed by the investigator unless specific deterioration criteria outlined in section 3.3.3 are confirmed.
- Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.
- Relocation outside of area of an active PEDIG site for this study within the next 36 months is not anticipated.
Who cannot join
- A patient is excluded for any of the following reasons:
- Any measurable heterotropia at distance (3 meters) or at near (1/3 meter) by cover/uncover testing. Note that patients with heterophoria are eligible.
- Previous documented strabismus (parental report must be confirmed by investigator)
- Manifest or latent nystagmus evident clinically
- Previous treatment of refractive error with glasses or contacts unless duration of glasses or contacts wear was one week or less and occurred more than 2 months prior to enrollment.
- Previous intraocular, refractive, or extraocular muscle surgery
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- Previous amblyopia treatment
- Previous vergence/accommodative therapy
- Parental concerns over learning or development
- Ocular co-morbidity that may reduce visual acuity
- Symptoms of blur or asthenopia
- Developmental delay diagnosed by pediatrician or Individualized Education Program (IEP)
- Known neurological anomalies (e.g. cerebral palsy, Down syndrome)
- Inability to perform visual acuity ATS-HOTV testing if ≥ 36 months of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University College of Optometry
Columbus, Ohio, 43210-1280
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, 84107
About this study
Official title: Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)
The purpose of this study is to compare visual acuity outcomes and development of strabismus after a 3-year follow-up period in children age 12 to <72 months with moderate hyperopia (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only after confirmation of pre-specified deterioration criteria.
Read the detailed description
Moderate and high hyperopia are associated with the development of strabismus and amblyopia. The primary aims of treatment for asymptomatic moderate and high hyperopia in preschool children are to facilitate the development of normal visual acuity and to prevent the development of esotropia and amblyopia. Treatment consists of optical correction, typically using glasses. For children with high hyperopia (>+5.00D) and without strabismus or amblyopia, there is general consensus that a correction should be prescribed. Nevertheless, for children with moderate hyperopia (+3.00D to +5.00D) without strabismus or amblyopia, there is less consensus among pediatric eye care professionals. A survey by Lyons et al found that for a 2-year-old child with hyperopia greater than +3.00D, 65% of optometrists would prescribe glasses compared to 25% of ophthalmologists; for a 4-year old with hyperopia greater than +3.00D, 67% of optometrists would prescribe compared with 42% of ophthalmologists. The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) recommends correcting +4.00D or more in 2 to 7 year olds and the American Academy of Ophthalmology recommends a threshold of +4.50D for correction in 2-to 3-year olds. Unlike ophthalmology, optometry does not provide specific recommendations based on age and level of refractive error. Such variation in practice highlights the lack of rigorously collected scientific evidence for the management of this condition. Across all levels of hyperopia, most ophthalmologists and optometrists usually prescribe less than the full cycloplegic refraction (71% in the Lyons survey) when no strabismus or amblyopia is present.
The rationale for proactively correcting moderate hyperopia in an asymptomatic child is the prevention of esotropia, amblyopia, or asthenopia. The argument against correcting moderate hyperopia in an asymptomatic child is the expense and inconvenience of glasses that might be unnecessary and the potential disruption of emmetropization in infants and toddlers. At present, it remains uncertain whether correction of moderate hyperopia is beneficial in terms of visual acuity outcomes or strabismus development. There is some evidence that using partial correction of hyperopia allows emmetropization to take place.
If refractive correction of moderate hyperopia does not reduce the incidence of amblyopia and/or esotropia compared to no refractive correction, then glasses can be avoided. However, if correcting moderate hyperopia does reduce the development of amblyopia and/or esotropia, then the benefits of preemptive refractive correction will have been identified.
- Conditions
- Hyperopia
- Being tested
- Glasses
- Keywords
- Hyperopia, Glasses
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlassesProcedure or surgery
Glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction.
| Study group | Role | What they receive |
|---|---|---|
| Glasses | Active comparator | Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study. Receives: Procedure: Glasses |
| Observation | Placebo comparator | Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. Receives: Procedure: Glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Confirmation of Failure Criteria
At the 36-month visit, each subject's condition will be classified as either failure or not a failure. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test.
The participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest
- Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone
- Strabismus surgery prior to the 36-month exam
- Distance VA below age norms in either eye
- ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye
- ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye
- Stereoacuity measured at near below age normal values
Measured: 36 months after randomization
Secondary outcomes (16)
Subgroup Analysis - Race
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Measured: 36 months after randomization
Subgroup Analysis - Gender
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Measured: 36 months
Subgroup Analysis - Family History of Amblyopia
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Measured: 36 months
Subgroup Analysis - Family History of Strabismus
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Measured: 36 months
Subgroup Analysis - SE Anisometropia
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Measured: 36 months
Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)
Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.
Measured: 36 months
Deterioration Criteria Met (Prior to 3 Years)
Estimate of Cumulative Deterioration Rate. Proportion of subjects who deteriorated during the course of the study were evaluated. Reasons for deterioration included stereoacuity, strabismus, treatment due to parental concern, and treatment that was prescribed against protocol.
Measured: Enrollment to <36 months
Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)
Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. Myopia is nearsightedness, or refractive error in which things are seen more clearly at near.
Mean change in SE refractive error is from baseline to 3 years, measured in diopters. Negative values indicate a shift in the myopic direction.
Measured: Enrollment to 3 years
Percentage of Participants With Hyperopia Reduction
Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years
Measured: Enrollment to 3 years
Best Visual Acuity
A treatment group comparison of the mean maximum visual acuity per subject at the masked 36-month visit (best visual acuity on any test with and without correction) will be performed using a t-test. Evaluated the best of the values reported with and without trial frames, during initial assessment and retest.
Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4)
A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.
Measured: 36 months after randomization
Failure to Meet Age-Normal VA at Distance
Proportion who failed to meet age-normal VA at distance at 3 years. Participants were classified as failing to meet age-normal visual acuity if, for either eye, distance visual acuity was below age-normal values both with and without trial frames, during initial assessment and re-test.
Measured: 36 months
Proportion With Amblyopia (at Distance)
A treatment group comparison of the proportion of subjects who developed amblyopia at distance during the course of the study will be performed using the Barnard's exact test.
Participants were classified as having amblyopia if any of the following criteria were met: 1) the interocular difference was ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye, or 2) the interocular differences was ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye. 3) VA less than age normal in each eye (presumed bilateral amblyopia)
Measured: 36 months after randomization
Binocular Near Visual Acuity
A treatment group comparison of the mean binocular near visual acuity (logarithm of minimum angle of resolution, or logMAR) at the 36-month outcome exam will be performed. Assessment completed in randomized correction.
Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision.
Measured: 36 months after randomization
Number of Participants With Strabismus at 3 Years
The number of participants who developed measurable heterotropia was estimated for each treatment group and the proportions were compared using Barnard's exact test.
Measured: 36 months after randomization
Mean Stereoacuity
Mean stereoacuity at 3 years was measured in log seconds of arc (log arcsec) (see explanation below). Evaluated the best of the values reported with and without trial frames, during initial assessment and retest.
Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Seconds of arc were converted to logarithm of seconds of arc, or log arcsec (in parentheses) as follows: 40 (1.60), 60(1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90), Nil (3.20)
Measured: 36 months
Failure to Meet Age-Normal Stereoacuity at 3 Years
Proportion who failed to meet age-normal stereoacuity. Participants were classified as failing to meet age-normal stereoacuity if near stereoacuity was below age-normal values both with and without trial frames, during initial assessment and re-test.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study start23 Feb 2012
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperopiaStudies 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
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Marjean Kulp, OD, MS, Study chair, Jaeb Center for Health ResearchDavid Petersen, MD, Study chair, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515475
- Sponsor's protocol ID
- HTS1
- Other IDs
- 2U10EY011751
- Acronym
- HTS1
- Status last verified
- Jul 2019
- First submitted
- 11 Jan 2012
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
Publications
Pediatric Eye Disease Investigator Group. Clinical factors associated with moderate hyperopia in preschool children with normal stereopsis and visual acuity. J AAPOS. 2016 Oct;20(5):455-457. doi: 10.1016/j.jaapos.2016.04.012. Epub 2016 Sep 20.
PubMed 27663627Pediatric Eye Disease Investigator Group; Kulp MT, Holmes JM, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Manny RE, Superstein R, Roberts TL, Avallone JM, Fishman DR, Erzurum SA, Leske DA, Christoff A. A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds. Ophthalmology. 2019 Jun;126(6):876-887. doi: 10.1016/j.ophtha.2018.12.049. Epub 2019 Jan 4.
PubMed 30615896Holmes JM, Kulp MT, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Crouch ER, Lorenzana IJ, Ticho BH, Verderber LC, Weise KK; Pediatric Eye Disease Investigator Group. A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age. Am J Ophthalmol. 2019 Dec;208:145-159. doi: 10.1016/j.ajo.2019.06.021. Epub 2019 Jun 28.
PubMed 31255587
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)
- ClinicalTrials.gov ID
- NCT01515475
- Acronym / sponsor ID
- HTS1 / HTS1
- Conditions
- Hyperopia
- Keywords
- Hyperopia, Glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Study start
- 23 Feb 2012 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Posted 9 May 2019
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 visual acuity outcomes and development of strabismus after a 3-year follow-up period in children age 12 to <72 months with moderate hyperopia (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only after confirmation of pre-specified deterioration criteria.
Detailed description
Moderate and high hyperopia are associated with the development of strabismus and amblyopia. The primary aims of treatment for asymptomatic moderate and high hyperopia in preschool children are to facilitate the development of normal visual acuity and to prevent the development of esotropia and amblyopia. Treatment consists of optical correction, typically using glasses. For children with high hyperopia (>+5.00D) and without strabismus or amblyopia, there is general consensus that a correction should be prescribed. Nevertheless, for children with moderate hyperopia (+3.00D to +5.00D) without strabismus or amblyopia, there is less consensus among pediatric eye care professionals. A survey by Lyons et al found that for a 2-year-old child with hyperopia greater than +3.00D, 65% of optometrists would prescribe glasses compared to 25% of ophthalmologists; for a 4-year old with hyperopia greater than +3.00D, 67% of optometrists would prescribe compared with 42% of ophthalmologists. The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) recommends correcting +4.00D or more in 2 to 7 year olds and the American Academy of Ophthalmology recommends a threshold of +4.50D for correction in 2-to 3-year olds. Unlike ophthalmology, optometry does not provide specific recommendations based on age and level of refractive error. Such variation in practice highlights the lack of rigorously collected scientific evidence for the management of this condition. Across all levels of hyperopia, most ophthalmologists and optometrists usually prescribe less than the full cycloplegic refraction (71% in the Lyons survey) when no strabismus or amblyopia is present.
The rationale for proactively correcting moderate hyperopia in an asymptomatic child is the prevention of esotropia, amblyopia, or asthenopia. The argument against correcting moderate hyperopia in an asymptomatic child is the expense and inconvenience of glasses that might be unnecessary and the potential disruption of emmetropization in infants and toddlers. At present, it remains uncertain whether correction of moderate hyperopia is beneficial in terms of visual acuity outcomes or strabismus development. There is some evidence that using partial correction of hyperopia allows emmetropization to take place.
If refractive correction of moderate hyperopia does not reduce the incidence of amblyopia and/or esotropia compared to no refractive correction, then glasses can be avoided. However, if correcting moderate hyperopia does reduce the development of amblyopia and/or esotropia, then the benefits of preemptive refractive correction will have been identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glasses | Active comparator | Procedure: GlassesGlasses are prescribed at enrollment and worn per protocol throughout the duration of the study. |
| Observation | Placebo comparator | Procedure: GlassesGlasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol. |
Who may qualify
- Ages
- 12 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Age 12 to < 72 months
- Refractive error between +3.00D and +6.00D SE (by cycloplegic refraction) in either eye
- Astigmatism < 1.50D in both eyes
- Spherical equivalent anisometropia ≤ +1.50D
- For children 36 to <72 months of age:
Key exclusion criteria (14 listed)
- Any measurable heterotropia at distance (3 meters) or at near (1/3 meter) by cover/uncover testing. Note that patients with heterophoria are eligible.
- Previous documented strabismus (parental report must be confirmed by investigator)
- Manifest or latent nystagmus evident clinically
- Previous treatment of refractive error with glasses or contacts unless duration of glasses or contacts wear was one week or less and occurred more than 2 months prior to enrollment.
- Previous intraocular, refractive, or extraocular muscle surgery
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 |
|---|---|---|
| GlassesGlasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. | Procedure or surgery | Glasses, Observation |
Primary outcome
Number of Participants With Confirmation of Failure Criteria
Time frame: 36 months after randomization
At the 36-month visit, each subject's condition will be classified as either failure or not a failure. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test. The participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest 1. Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone 2. Strabismus surgery prior to the 36-month exam 3. Distance VA below age norms in either eye 4. ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye 5. ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye 6. Stereoacuity measured at near below age normal values
16 secondary outcomes
Subgroup Analysis - Race
Time frame: 36 months after randomization
Subgroup Analysis - Gender
Time frame: 36 months
Subgroup Analysis - Family History of Amblyopia
Time frame: 36 months
Subgroup Analysis - Family History of Strabismus
Time frame: 36 months
Subgroup Analysis - SE Anisometropia
Time frame: 36 months
Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)
Time frame: 36 months
Deterioration Criteria Met (Prior to 3 Years)
Time frame: Enrollment to <36 months
Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)
Time frame: Enrollment to 3 years
Percentage of Participants With Hyperopia Reduction
Time frame: Enrollment to 3 years
Best Visual Acuity
Time frame: 36 months after randomization
Failure to Meet Age-Normal VA at Distance
Time frame: 36 months
Proportion With Amblyopia (at Distance)
Time frame: 36 months after randomization
Binocular Near Visual Acuity
Time frame: 36 months after randomization
Number of Participants With Strabismus at 3 Years
Time frame: 36 months after randomization
Mean Stereoacuity
Time frame: 36 months
Failure to Meet Age-Normal Stereoacuity at 3 Years
Time frame: 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27663627Pediatric Eye Disease Investigator Group. Clinical factors associated with moderate hyperopia in preschool children with normal stereopsis and visual acuity. J AAPOS. 2016 Oct;20(5):455-457. doi: 10.1016/j.jaapos.2016.04.012. Epub 2016 Sep 20.
- Results publication: PubMed 30615896Pediatric Eye Disease Investigator Group; Kulp MT, Holmes JM, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Manny RE, Superstein R, Roberts TL, Avallone JM, Fishman DR, Erzurum SA, Leske DA, Christoff A. A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds. Ophthalmology. 2019 Jun;126(6):876-887. doi: 10.1016/j.ophtha.2018.12.049. Epub 2019 Jan 4.
- Results publication: PubMed 31255587Holmes JM, Kulp MT, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Crouch ER, Lorenzana IJ, Ticho BH, Verderber LC, Weise KK; Pediatric Eye Disease Investigator Group. A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age. Am J Ophthalmol. 2019 Dec;208:145-159. doi: 10.1016/j.ajo.2019.06.021. Epub 2019 Jun 28.
- Individual participant dataSharing planned: Yes. In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
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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.
Marjean Kulp, OD, MS study chair
Jaeb Center for Health Research
David Petersen, MD study chair
Jaeb Center for Health Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glasses in people with Hyperopia, run by Jaeb Center for Health Research at 2 sites 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 13 inclusion and 14 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: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Confirmation of Failure Criteria (time frame: 36 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01515475, which also lists 3 linked publications.
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 16 Jul 2019.