An interventional study of Spectacles - Clinically Derived and Spectacles - Metric Technique #1 Derived in Vision, Low, sponsored by University of Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by University of Houston · Not applicable, Interventional, and Treatment
This study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with Down syndrome can provide an improvement in visual acuity over that obtained with spectacle prescriptions based on standard clinical prescribing techniques. The objectively derived prescriptions are derived using strategies to optimize retinal image quality as measured by image quality metrics, and thus these prescriptions will be referred to as metric-derived.
Individuals with Down syndrome suffer from significant ocular complications including high levels of lower-order refractive error (sphere and cylinder) and elevated levels of higher-order aberrations. These optical factors likely contribute to the poor acuity observed in this population. Current clinical prescribing practices may under-serve this community, as the cognitive demands of the subjective refraction sequence are difficult for this population and often leave clinicians to prescribe from objective clinical findings that target full correction of sphero-cylindrical refractive error. This prescribing practice can lead to sub-par outcomes given the fact that full lower-order corrections can exacerbate the effects of higher-order aberrations in more aberrated eyes.
For this study, individuals with Down syndrome will be dispensed three pairs of spectacles for 2 months each, in random order: one clinically-derived, and two objectively-derived refractions based upon methods designed to optimize a given metric of retinal image quality which takes into consideration the wavefront aberration measurements of the eye. Both initial and adapted visual acuity in the presence of each correction will be evaluated to determine whether the objectively-derived refractions outperform clinically-derived refractions.
98 studies on the registry are indexed under Vision, Low; 23 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 78 interventional studies indexed under Vision, Low.
Browse Vision, Low studies →University of Houston is the lead sponsor of 102 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
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Exclusion Criteria:
Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.
Device: Spectacles - Clinically Derived · Device: Spectacles - Metric Technique #1 Derived · Device: Spectacles - Metric Technique #2 Derived
Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.
Device: Spectacles - Clinically Derived · Device: Spectacles - Metric Technique #1 Derived · Device: Spectacles - Metric Technique #2 Derived
Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived prescription, and lastly the metric-derived #2 prescription.
Device: Spectacles - Clinically Derived · Device: Spectacles - Metric Technique #1 Derived · Device: Spectacles - Metric Technique #2 Derived
Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived prescription, and lastly the metric-derived #1 prescription.
Device: Spectacles - Clinically Derived · Device: Spectacles - Metric Technique #1 Derived · Device: Spectacles - Metric Technique #2 Derived
Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2 prescription, and lastly the clinically derived prescription.
Device: Spectacles - Clinically Derived · Device: Spectacles - Metric Technique #1 Derived · Device: Spectacles - Metric Technique #2 Derived
Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1 prescription, and lastly the clinically derived prescription.
Device: Spectacles - Clinically Derived · Device: Spectacles - Metric Technique #1 Derived · Device: Spectacles - Metric Technique #2 Derived
Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.
Also known as: Glasses, Prescription Lenses, Spectacles
Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.
Also known as: Glasses, Prescription Lenses, Spectacles
Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.
Also known as: Glasses, Prescription Lenses, Spectacles
Adapted Visual Acuity
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
Time frame: two months
Initial Visual Acuity
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
Time frame: 1 day
Spectacle Wear Time
Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple.
Time frame: two months
Spectacle Assessment Survey Question 1
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'Do you like wearing this pair of glasses?' Responses were coded 1 through 5 with 5 = large smile.
Time frame: two months
Spectacle Assessment Survey Question 2
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking far away?' Responses were coded 1 through 5 with 5 = large smile.
Time frame: two months
Spectacle Assessment Survey Question 3
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking up close?' Responses were coded 1 through 5 with 5 = large smile.
Time frame: two months
| Milestone | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 5 | 5 | 5 | 5 |
| Completed | 5 | 5 | 5 | 5 | 5 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 5 | 5 | 5 | 5 |
| Completed | 5 | 5 | 5 | 5 | 5 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 5 | 5 | 5 | 5 |
| Completed | 5 | 5 | 4 | 5 | 5 | 5 |
| Not completed | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 | 0 | 0 | 0 |
| Milestone | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Started | 5 | 5 | 5 | 5 | 5 | 5 |
| Completed | 5 | 5 | 5 | 5 | 5 | 5 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
| logMAR | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Period 2 Treatment 1 Dispense to 2 Months Wear | 0.256 ± 0.110 | 0.440 ± 0.240 | 0.356 ± 0.149 | 0.284 ± 0.089 | 0.300 ± 0.163 | 0.364 ± 0.048 |
| Period 3 Treatment 2 Dispense to 2 Months Wear | 0.272 ± 0.135 | 0.412 ± 0.215 | 0.370 ± 0.093 | 0.316 ± 0.157 | 0.256 ± 0.344 | 0.316 ± 0.091 |
| Period 4 Treatment 3 Dispense to 2 Months Wear | 0.288 ± 0.100 | 0.424 ± 00.238 | 0.320 ± 0.117 | 0.276 ± 0.140 | 0.216 ± 0.119 | 0.372 ± 0.091 |
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
| logMAR | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Treatment 1 Initial Dispense | 0.28 ± 0.14 | 0.43 ± 0.25 | 0.34 ± 0.22 | 0.28 ± 0.13 | 0.29 ± 0.35 | 0.33 ± 0.09 |
| Treatment 2 Initial Dispense | 0.25 ± 0.08 | 0.43 ± 0.25 | 0.36 ± 0.18 | 0.30 ± 0.22 | 0.30 ± 0.15 | 0.34 ± 0.07 |
| Treatment 3 Initial Dispense | 0.31 ± 0.40 | 0.44 ± 0.24 | 0.40 ± 0.16 | 0.32 ± 0.18 | 0.28 ± 0.14 | 0.40 ± 0.05 |
Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple.
| Hours | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Period 2 Treatment 1 Dispense to 2 Months Wear | 11.93 ± 4.95 | 13.15 ± 3.96 | 10.48 ± 4.08 | 9.81 ± 4.32 | 8.40 ± 4.29 | 11.62 ± 2.55 |
| Period 3 Treatment 2 Dispense to 2 Months Wear | 9.50 ± 5.50 | 12.68 ± 5.82 | 12.31 ± 4.74 | 9.67 ± 4.85 | 9.26 ± 4.17 | 11.25 ± 2.96 |
| Period 4 Treatment 3 Dispense to 2 Months Wear | 11.61 ± 6.05 | 13.32 ± 4.53 | 11.95 ± 4.18 | 9.47 ± 5.12 | 9.54 ± 4.34 | 11.31 ± 3.06 |
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'Do you like wearing this pair of glasses?' Responses were coded 1 through 5 with 5 = large smile.
| score on a scale | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Period 2 Treatment 1 Dispense to 2 Months Wear | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (2 to 5) | 5 (5 to 5) |
| Period 3 Treatment 2 Dispense to 2 Months Wear | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (4 to 5) | 5 (4 to 5) | 4 (4 to 5) |
| Period 4 Treatment 3 Dispense to 2 Months Wear | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 4 (4 to 5) |
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking far away?' Responses were coded 1 through 5 with 5 = large smile.
| score on a scale | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Period 2 Treatment 1 Dispense to 2 Months Wear | 5 (5 to 5) | 5 (4 to 5) | 5 (5 to 5) | 5 (4 to 5) | 5 (5 to 5) | 5 (4 to 5) |
| Period 3 Treatment 2 Dispense to 2 Months Wear | 5 (5 to 5) | 5 (5 to 5) | 4.5 (4 to 5) | 5 (5 to 5) | 5 (4 to 5) | 4 (4 to 5) |
| Period 4 Treatment 3 Dispense to 2 Months Wear | 5 (5 to 5) | 5 (4 to 5) | 5 (5 to 5) | 5 (4 to 5) | 5 (5 to 5) | 5 (5 to 5) |
Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking up close?' Responses were coded 1 through 5 with 5 = large smile.
| score on a scale | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical |
|---|---|---|---|---|---|---|
| Period 2 Treatment 1 Dispense to 2 Months Wear | 5 (5 to 5) | 5 (5 to 5) | 5 (4 to 5) | 5 (4 to 5) | 5 (5 to 5) | 5 (5 to 5) |
| Period 3 Treatment 2 Dispense to 2 Months Wear | 5 (5 to 5) | 5 (5 to 5) | 5 (4.5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) |
| Period 4 Treatment 3 Dispense to 2 Months Wear | 5 (5 to 5) | 5 (4 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (5 to 5) | 5 (4 to 5) |
Collected over Adverse event data were collected from the time of dispense of the first treatment through follow up of the final dispensed treatment (6 months total).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clinical | 0/29 (0%) | 0/29 (0%) | 7/29 (24.1%) |
| Metric #1 | 0/30 (0%) | 0/30 (0%) | 5/30 (16.7%) |
| Metric #2 | 0/30 (0%) | 0/30 (0%) | 4/30 (13.3%) |
| Event | Clinical | Metric #1 | Metric #2 |
|---|---|---|---|
| Vision complaint related to comparison with earlier randomized treatment or habitual spectaclesEye disorders | 7/29 | 1/30 | 2/30 |
| Upper Respiratory SymptomsRespiratory, thoracic and mediastinal disorders | 0/29 | 4/30 | 2/30 |
Analysis was performed by participant. There was not a unit other than participants assigned to Arms/Groups.
| Age, Continuous(years) | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical | Total |
|---|---|---|---|---|---|---|---|
| Mean | 32 ± 9 | 30 ± 13 | 34 ± 9 | 28 ± 12 | 24 ± 4 | 28 ± 10 | 29 ± 10 |
| Sex: Female, Male(Participants) | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical | Total |
|---|---|---|---|---|---|---|---|
| Female | 3 | 1 | 3 | 1 | 3 | 4 | 15 |
| Male | 2 | 4 | 2 | 4 | 2 | 1 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 1 | 1 | 1 | 2 | 7 |
| Not Hispanic or Latino | 4 | 4 | 4 | 4 | 4 | 3 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 0 | 1 | 0 | 1 | 4 |
| White | 3 | 3 | 5 | 3 | 5 | 4 | 23 |
| More than one race | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical | Total |
|---|---|---|---|---|---|---|---|
| United States | 5 | 5 | 5 | 5 | 5 | 5 | 30 |
| Adaptive Behavior Standard Score(Standard Score) | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical | Total |
|---|---|---|---|---|---|---|---|
| Median | 74 (42 to 99) | 73 (33 to 85) | 59 (22 to 78) | 60 (40 to 79) | 57 (40 to 71) | 59 (54 to 81) | 60 (22 to 99) |
| Binocular Distance Visual Acuity(logMAR) | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical | Total |
|---|---|---|---|---|---|---|---|
| Mean | 0.30 ± .10 | 0.48 ± 0.29 | 0.40 ± 0.13 | 0.38 ± 0.15 | 0.46 ± 0.16 | 0.30 ± 0.14 | 0.39 ± 0.17 |
| Number presenting with spectacles(Participants) | Clinical, Then Metric #1, Then Metric #2 | Clinical, Then Metric #2, Then Metric #1 | Metric #1, Then Clinical, Then Metric #2 | Metric #2, Then Clinical, Then Metric #1 | Metric #1, Then Metric #2, Then Clinical | Metric #2, Then Metric #1, Then Clinical | Total |
|---|---|---|---|---|---|---|---|
| Count of participants | 4 | 4 | 3 | 4 | 2 | 4 | 21 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Jun 2019, 16 months.
Results were first posted in Oct 2021, 2 years 4 months after primary completion. A results delay was requested in May 2020.
Of 38 interventional studies with no phase under Vision, Low, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 56. This study's 16 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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