Vision, LowNCT03367793
Spectacles for Patients With Down Syndrome
A study testing Spectacles - Clinically Derived, Spectacles - Metric Technique #1 Derived and Spectacles - Metric Technique #2 Derived in people with Vision, Low, run by University of Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vision, Low
- What is being tested?
- Spectacles - Clinically Derived, Spectacles - Metric Technique #1 Derived and Spectacles - Metric Technique #2 Derived
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 5 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Down syndrome
Who cannot join
- Nystagmus (Involuntary beating movement of the eyes)
- Visually significant media opacities (e.g. cataracts or corneal scars)
- Strabismic amblyopia (reduced vision in one eye related to a constant eye-turn)
- Anisometropic amblyopia (reduced vision in one eye related to a long-standing uncompensated difference in prescription between the two eyes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Optimum Spectacle Prescriptions for Patients With Down Syndrome
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.
Read the detailed description
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.
- Conditions
- Vision, Low
- Being tested
- Spectacles - Clinically Derived, Spectacles - Metric Technique #1 Derived, Spectacles - Metric Technique #2 Derived
- Medical subject headings
- Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectacles - Clinically DerivedDevice
Also called Glasses, Prescription Lenses, Spectacles
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.
Spectacles - Metric Technique #1 DerivedDevice
Also called 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.
Spectacles - Metric Technique #2 DerivedDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical, then Metric #1, then Metric #2 | Experimental | 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. Receives: Device: Spectacles - Clinically Derived; Device: Spectacles - Metric Technique #1 Derived; Device: Spectacles - Metric Technique #2 Derived |
| Clinical, then Metric #2, then Metric #1 | Experimental | 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. Receives: Device: Spectacles - Clinically Derived; Device: Spectacles - Metric Technique #1 Derived; Device: Spectacles - Metric Technique #2 Derived |
| Metric #1, then Clinical, then Metric #2 | Experimental | 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. Receives: Device: Spectacles - Clinically Derived; Device: Spectacles - Metric Technique #1 Derived; Device: Spectacles - Metric Technique #2 Derived |
| Metric #2, then Clinical, then Metric #1 | Experimental | 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. Receives: Device: Spectacles - Clinically Derived; Device: Spectacles - Metric Technique #1 Derived; Device: Spectacles - Metric Technique #2 Derived |
| Metric #1, then Metric #2, then Clinical | Experimental | 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. Receives: Device: Spectacles - Clinically Derived; Device: Spectacles - Metric Technique #1 Derived; Device: Spectacles - Metric Technique #2 Derived |
| Metric #2, then Metric #1, then Clinical | Experimental | 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. Receives: Device: Spectacles - Clinically Derived; Device: Spectacles - Metric Technique #1 Derived; Device: Spectacles - Metric Technique #2 Derived |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapted Visual Acuity
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
Measured: two months
Secondary outcomes (5)
Initial Visual Acuity
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start26 Jan 2018
- Primary completion10 Jun 2019
- Study completion5 Dec 2019
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 Vision, LowStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather A. Anderson, University of Houston
- Investigators
- Heather A Anderson, OD, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367793
- Sponsor's protocol ID
- EY024590
- Status last verified
- Sep 2021
- First submitted
- 5 Dec 2017
- Last updated
- 25 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Plaumann MD, Marsack JD, Anderson HA. Comparing visual acuity and optimized visual image quality for individuals with and without Down syndrome. Optom Vis Sci. 2025 Oct 1;102(10):622-628. doi: 10.1097/OPX.0000000000002301.
PubMed 40965370Anderson HA, Marsack JD, Benoit JS, Manny RE, Fern KD. Visual Acuity Outcomes in a Randomized Trial of Wavefront Metric-optimized Refractions in Adults with Down Syndrome. Optom Vis Sci. 2022 Jan 1;99(1):58-66. doi: 10.1097/OPX.0000000000001834.
PubMed 34882603Anderson HA, Benoit JS, Marsack JD, Manny RE, Ravikumar A, Fern KD, Trast KR. A Randomized Trial of Objective Spectacle Prescriptions for Adults with Down Syndrome: Baseline Data and Methods. Optom Vis Sci. 2021 Jan 1;98(1):88-99. doi: 10.1097/OPX.0000000000001631.
PubMed 33394936
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Optimum Spectacle Prescriptions for Patients With Down Syndrome
- ClinicalTrials.gov ID
- NCT03367793
- Acronym / sponsor ID
- EY024590
- Conditions
- Vision, Low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 25 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Clinical, then Metric #1, then Metric #2 | Experimental | Device: Spectacles - Clinically Derived, Device: Spectacles - Metric Technique #1 Derived, Device: Spectacles - Metric Technique #2 DerivedEach 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. |
| Clinical, then Metric #2, then Metric #1 | Experimental | Device: Spectacles - Clinically Derived, Device: Spectacles - Metric Technique #1 Derived, Device: Spectacles - Metric Technique #2 DerivedEach 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. |
| Metric #1, then Clinical, then Metric #2 | Experimental | Device: Spectacles - Clinically Derived, Device: Spectacles - Metric Technique #1 Derived, Device: Spectacles - Metric Technique #2 DerivedEach 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. |
| Metric #2, then Clinical, then Metric #1 | Experimental | Device: Spectacles - Clinically Derived, Device: Spectacles - Metric Technique #1 Derived, Device: Spectacles - Metric Technique #2 DerivedEach 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. |
| Metric #1, then Metric #2, then Clinical | Experimental | Device: Spectacles - Clinically Derived, Device: Spectacles - Metric Technique #1 Derived, Device: Spectacles - Metric Technique #2 DerivedEach 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. |
| Metric #2, then Metric #1, then Clinical | Experimental | Device: Spectacles - Clinically Derived, Device: Spectacles - Metric Technique #1 Derived, Device: Spectacles - Metric Technique #2 DerivedEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Down syndrome
Key exclusion criteria (4 listed)
- Nystagmus (Involuntary beating movement of the eyes)
- Visually significant media opacities (e.g. cataracts or corneal scars)
- Strabismic amblyopia (reduced vision in one eye related to a constant eye-turn)
- Anisometropic amblyopia (reduced vision in one eye related to a long-standing uncompensated difference in prescription between the two eyes)
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 |
|---|---|---|
| Spectacles - Clinically DerivedAlso: Glasses, Prescription Lenses, SpectaclesPrescription 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. | Device | Clinical, then Metric #1, then Metric #2, Clinical, then Metric #2, then Metric #1, Metric #1, then Clinical, then Metric #2, Metric #1, then Metric #2, then Clinical, Metric #2, then Clinical, then Metric #1, Metric #2, then Metric #1, then Clinical |
| Spectacles - Metric Technique #1 DerivedAlso: Glasses, Prescription Lenses, SpectaclesPrescription 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. | Device | Clinical, then Metric #1, then Metric #2, Clinical, then Metric #2, then Metric #1, Metric #1, then Clinical, then Metric #2, Metric #1, then Metric #2, then Clinical, Metric #2, then Clinical, then Metric #1, Metric #2, then Metric #1, then Clinical |
| Spectacles - Metric Technique #2 DerivedAlso: Glasses, Prescription Lenses, SpectaclesPrescription 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. | Device | Clinical, then Metric #1, then Metric #2, Clinical, then Metric #2, then Metric #1, Metric #1, then Clinical, then Metric #2, Metric #1, then Metric #2, then Clinical, Metric #2, then Clinical, then Metric #1, Metric #2, then Metric #1, then Clinical |
Primary outcome
Adapted Visual Acuity
Time frame: two months
Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.
5 secondary outcomes
Initial Visual Acuity
Time frame: 1 day
Spectacle Wear Time
Time frame: two months
Spectacle Assessment Survey Question 1
Time frame: two months
Spectacle Assessment Survey Question 2
Time frame: two months
Spectacle Assessment Survey Question 3
Time frame: two months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40965370Plaumann MD, Marsack JD, Anderson HA. Comparing visual acuity and optimized visual image quality for individuals with and without Down syndrome. Optom Vis Sci. 2025 Oct 1;102(10):622-628. doi: 10.1097/OPX.0000000000002301.
- Derived from this study: PubMed 34882603Anderson HA, Marsack JD, Benoit JS, Manny RE, Fern KD. Visual Acuity Outcomes in a Randomized Trial of Wavefront Metric-optimized Refractions in Adults with Down Syndrome. Optom Vis Sci. 2022 Jan 1;99(1):58-66. doi: 10.1097/OPX.0000000000001834.
- Derived from this study: PubMed 33394936Anderson HA, Benoit JS, Marsack JD, Manny RE, Ravikumar A, Fern KD, Trast KR. A Randomized Trial of Objective Spectacle Prescriptions for Adults with Down Syndrome: Baseline Data and Methods. Optom Vis Sci. 2021 Jan 1;98(1):88-99. doi: 10.1097/OPX.0000000000001631.
- Individual participant dataSharing planned: Undecided
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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.
Heather A Anderson, OD, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacles - Clinically Derived, Spectacles - Metric Technique #1 Derived and Spectacles - Metric Technique #2 Derived in people with Vision, Low, run by University of Houston 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 1 inclusion and 4 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 25 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2021). 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?
Adapted Visual Acuity (time frame: two months). 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 NCT03367793, 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 25 Oct 2021.