Spectacles for Patients With Down Syndrome

NCT03367793 | Completed Results FDA Device

• 1 other identifier: EY024590
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vision, Low

Outcome Measures

Primary Outcomes (1)

• Adapted Visual Acuity

  Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.

  two months

Secondary Outcomes (5)

• Initial Visual Acuity

  1 day

• Spectacle Wear Time

  two months

• Spectacle Assessment Survey Question 1

  two months

• Spectacle Assessment Survey Question 2

  two months

• Spectacle Assessment Survey Question 3

  two months

Study Arms (6)

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.

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.

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.

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.

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.

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.

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

Interventions

Spectacles - Clinically Derived DEVICE

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

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 Derived DEVICE

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

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 Derived DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Down syndrome

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (2)

• 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.

  PMID: 34882603 DERIVED

• 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.

  PMID: 33394936 DERIVED

MeSH Terms

Conditions

Vision, Low

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Dr. Heather Anderson, Study PI
• Organization: Ohio State University College of Optometry

anderson.3881@osu.edu

614-247-5825

Study Officials

• Heather A Anderson, OD, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 11, 2017
• Study Start: January 26, 2018
• Primary Completion: June 10, 2019
• Study Completion: December 5, 2019
• Last Updated: October 25, 2021
• Results First Posted: October 25, 2021

Record last verified: 2021-09

Locations

US (1)