Spectacles for Patients With Down Syndrome

University of Houston

Status: Completed

Conditions: Vision, Low

Treatments: Device: Spectacles - Metric Technique #2 Derived; Device: Spectacles - Clinically Derived; Device: Spectacles - Metric Technique #1 Derived

Study type: Interventional

Funder types: Other

Identifiers

NCT03367793

EY024590

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 6 patient groups

Clinical, then Metric #1, then Metric #2

Experimental group

Description:

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.

Treatment:

Device: Spectacles - Metric Technique #1 Derived

Device: Spectacles - Clinically Derived

Device: Spectacles - Metric Technique #2 Derived

Clinical, then Metric #2, then Metric #1

Experimental group

Description:

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.

Treatment:

Device: Spectacles - Metric Technique #1 Derived

Device: Spectacles - Clinically Derived

Device: Spectacles - Metric Technique #2 Derived

Metric #1, then Clinical, then Metric #2

Experimental group

Description:

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.

Treatment:

Device: Spectacles - Metric Technique #1 Derived

Device: Spectacles - Clinically Derived

Device: Spectacles - Metric Technique #2 Derived

Metric #2, then Clinical, then Metric #1

Experimental group

Description:

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.

Treatment:

Device: Spectacles - Metric Technique #1 Derived

Device: Spectacles - Clinically Derived

Device: Spectacles - Metric Technique #2 Derived

Metric #1, then Metric #2, then Clinical

Experimental group

Description:

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.

Treatment:

Device: Spectacles - Metric Technique #1 Derived

Device: Spectacles - Clinically Derived

Device: Spectacles - Metric Technique #2 Derived

Metric #2, then Metric #1, then Clinical

Experimental group

Description:

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.

Treatment:

Device: Spectacles - Metric Technique #1 Derived

Device: Spectacles - Clinically Derived

Device: Spectacles - Metric Technique #2 Derived