Clinical trial NCT03367793: Spectacles for Patients With Down Syndrome
Official title: Identification of Optimum Spectacle Prescriptions for Patients With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision, Low
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Adapted Visual Acuity
timeFrame: two months
Secondary outcomes:
measure: Initial Visual Acuity
timeFrame: 1 day
measure: Spectacle Wear Time
timeFrame: two months
measure: Spectacle Assessment Survey Question 1
timeFrame: two months
measure: Spectacle Assessment Survey Question 2
timeFrame: two months
measure: Spectacle Assessment Survey Question 3
timeFrame: two months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Heather A Anderson, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson 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.
citation: Anderson 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.