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Spectacles for Patients With Down Syndrome

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ClinicalTrials.gov Identifier: NCT03367793
Recruitment Status : Not yet recruiting
First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Vision, Low Device: Clinical Device: Metric #1 Device: Metric #2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Identification of Optimum Spectacle Prescriptions for Patients With Down Syndrome
Anticipated Study Start Date : December 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Clinical, then Metric #1, then Metric #2
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: Clinical
Prescription spectacle lenses determined by clinically derived techniques.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #1
Prescription spectacle lenses determined by metric-derived objective technique #1.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #2
Prescription spectacle lenses determined by metric-derived objective technique #2.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Experimental: Clinical, then Metric #2, then Metric #1
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: Clinical
Prescription spectacle lenses determined by clinically derived techniques.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #1
Prescription spectacle lenses determined by metric-derived objective technique #1.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #2
Prescription spectacle lenses determined by metric-derived objective technique #2.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Experimental: Metric #1, then Clinical, then Metric #2
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: Clinical
Prescription spectacle lenses determined by clinically derived techniques.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #1
Prescription spectacle lenses determined by metric-derived objective technique #1.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #2
Prescription spectacle lenses determined by metric-derived objective technique #2.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Experimental: Metric #2, then Clinical, then Metric #1
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: Clinical
Prescription spectacle lenses determined by clinically derived techniques.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #1
Prescription spectacle lenses determined by metric-derived objective technique #1.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #2
Prescription spectacle lenses determined by metric-derived objective technique #2.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Experimental: Metric #1, then Metric #2, then Clinical
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: Clinical
Prescription spectacle lenses determined by clinically derived techniques.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #1
Prescription spectacle lenses determined by metric-derived objective technique #1.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #2
Prescription spectacle lenses determined by metric-derived objective technique #2.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Experimental: Metric #2, then Metric #1, then Clinical
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: Clinical
Prescription spectacle lenses determined by clinically derived techniques.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #1
Prescription spectacle lenses determined by metric-derived objective technique #1.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles
Device: Metric #2
Prescription spectacle lenses determined by metric-derived objective technique #2.
Other Names:
  • Glasses
  • Prescription Lenses
  • Spectacles


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Initial Visual Acuity [ Time Frame: 1 day ]
    Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.

  2. Spectacle Wear Time [ Time Frame: two months ]
    Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple.

  3. Spectacle Assessment Survey [ Time Frame: two months ]
    Four question survey with each question rated on a 5 point frown to smile scale. Questions target whether the subject likes the spectacles, feels they have good vision at distance and near, and feels that they see better with the spectacles than without.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Down syndrome

Exclusion Criteria:

  • 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367793


Contacts
Contact: Heather A Anderson, OD, PhD 713-743-1908 handerson@central.uh.edu

Sponsors and Collaborators
University of Houston
Investigators
Principal Investigator: Heather A Anderson, OD, PhD University of Houston
More Information

Responsible Party: Heather A. Anderson, Associate Professor, University of Houston
ClinicalTrials.gov Identifier: NCT03367793     History of Changes
Other Study ID Numbers: EY024590
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Down Syndrome
Vision, Low
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Vision Disorders
Sensation Disorders
Eye Diseases
Signs and Symptoms
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents