Dilated vs Non-Dilated Eye Exams for Down Syndrome

Recruiting at 1 trial location

Overseen By Heather Anderson, OD, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University

Disqualifiers: Ocular nystagmus, Ocular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

42 Participants Needed

Trial Summary

What is the purpose of this trial?

Individuals with Down syndrome (DS) live with visual deficits due, in part, to elevated levels of higher-order optical aberrations (HOA). HOAs are distortions/abnormalities in the structure of the refractive components of the eye (i.e. the cornea and the lens) that, if present, can result in poor quality focus on the retina, thus negatively impacting vision. HOAs in the general population are overall low, and thus not ordinarily considered during the eye examination and determination of refractive correction. However, for some populations, such as individuals with DS, HOAs are elevated, and thus the commonly used clinical techniques to determine refractive corrections may fall short. The most common clinical technique for refractive correction determination is subjective refraction whereby a clinician asks the patient to compare different lens options and select the lens that provides the best visual outcome. Given the cognitive demands of the standard subjective refraction technique, clinicians rely on objective clinical techniques to prescribe optical corrections for individuals with DS. This is problematic, because it may result in errors for eyes with elevated HOA given that these techniques do not include measurement of the HOAs. The proposed research evaluates the use of objective wavefront measurements that quantify the HOAs of the eye as a basis for refractive correction determination for patients with DS. The specific aim is to determine whether dilation of the eyes is needed prior to objective wavefront measurements. Dilation of the eyes increases the ability to measure the optical quality of the eye and paralyzes accommodation (the natural focusing mechanism of the eye), which could be beneficial in determining refractions. However, the use of dilation lengthens the process for determining prescriptions and may be less desirable for patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Dilated vs Non-Dilated Eye Exams for Down Syndrome is an effective treatment?

The available research shows that using new objective methods for eye exams, like wavefront metric-optimized refractions, can help improve vision quality for people with Down syndrome. These methods are more effective than standard clinical techniques, which often struggle to find the best corrective lenses for this group. One study found that these new methods can lead to better visual acuity, which means clearer vision. This suggests that these eye exams are a promising treatment for improving vision in individuals with Down syndrome. ^{1 2 3 4 5}

What safety data exists for eye exams in Down syndrome?

The research does not directly address safety data for dilated vs non-dilated eye exams in individuals with Down syndrome. However, it explores different refraction methods, including metric-optimized refractions and objective refraction based on wavefront aberration measures, which may offer insights into their effectiveness and potential benefits. The studies focus on optimizing visual corrections and understanding refractive errors, but specific safety data is not provided. ^{1 2 5 6 7}

Is the treatment Dilated Refraction, Non-Dilated Refraction promising for people with Down Syndrome?

Yes, this treatment is promising because it uses advanced methods to improve vision correction for people with Down Syndrome, where regular techniques might not work as well. It can help provide better visual quality, which can make daily life easier for them. ^{1 2 4 5 8}

Research Team

Heather Anderson, OD, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for individuals with Down Syndrome who can have their eyes dilated, fixate on objects for study measures, and respond to visual acuity testing. It's not suitable for those with involuntary eye movements (ocular nystagmus), past eye surgeries (except strabismus surgery), or conditions like corneal or lenticular opacities and other ocular diseases.

Inclusion Criteria

You can focus and stay still for the tests in the study.

Your blood vessels are able to be widened.

Able to respond for visual acuity testing

Exclusion Criteria

History of ocular or refractive surgery (strabismus surgery is okay)

You have uncontrollable eye movements.

You have cloudiness in your eye's cornea or lens.

Treatment Details

Interventions

• Dilated Refraction
• Non-Dilated Refraction

Trial Overview The study is examining whether dilating the eyes before measuring wavefront errors (distortions in vision) provides a better basis for prescribing glasses compared to non-dilated measurements. This could help improve vision correction in people with Down Syndrome.

Participant Groups

Group I: Non-dilated first, dilated second Experimental Treatment 2 Interventions

Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained before dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained after dilation.

Group II: Dilated first, non-dilated second Experimental Treatment 2 Interventions

Each participant will perform vision testing first through a prescription determined from wavefront measurements obtained after dilation. Second, each participation will perform vision testing through a prescription determined from wavefront measurements obtained before dilation.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

Findings from Research

In a study of 30 adults with Down syndrome, refractions using metric-optimised methods (visual Strehl ratio and pupil fraction tessellated) showed significant differences compared to standard clinical techniques, with the clinical method resulting in less accurate corrections.

The differences in refraction were linked to higher order aberrations and myopic refractive errors, suggesting that traditional clinical methods may not adequately address the unique visual needs of individuals with Down syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dioptric differences between clinically determined and metric-optimised refractions for adults with Down syndrome. Plaumann, MD., Marsack, JD., Benoit, JS., et al.[2023]

A clinical trial involving 30 adults with Down syndrome is investigating new objective methods for determining spectacle corrections, which may improve visual quality and daily living activities.

The study found good repeatability in measuring distance visual acuity, suggesting that adults with Down syndrome can reliably participate in assessments, even with reduced visual acuity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Objective Spectacle Prescriptions for Adults with Down Syndrome: Baseline Data and Methods. Anderson, HA., Benoit, JS., Marsack, JD., et al.[2023]

In a study involving 30 adults with Down syndrome, objective refractions using wavefront aberration measures provided visual acuity outcomes comparable to those obtained from expert clinical refractions, indicating that this method could be a useful alternative for determining refractive corrections in this population.

No significant differences in visual acuity were found between the different refraction methods after two months of wear, suggesting that both clinical and objective refraction techniques are equally effective for improving vision in adults with intellectual disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual Acuity Outcomes in a Randomized Trial of Wavefront Metric-optimized Refractions in Adults with Down Syndrome. Anderson, HA., Marsack, JD., Benoit, JS., et al.[2023]

Photoscreening is highly sensitive (93%) in detecting treatable ocular conditions in children with Down syndrome, making it a reliable initial screening tool after a comprehensive eye exam.

However, the specificity of photoscreening is lower (35% for MTI and 55% for VR), indicating that while it can effectively identify potential issues, it may also produce a number of false positives, suggesting the need for follow-up evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The accuracy of photoscreening at detecting treatable ocular conditions in children with Down syndrome. Yanovitch, T., Wallace, DK., Freedman, SF., et al.[2021]

In a study involving 27 adults with Down syndrome and 24 control subjects, it was found that the difference in objective refraction between 4-mm and 6-mm pupil diameters was significantly greater in individuals with Down syndrome (0.51 diopters) compared to controls (0.19 diopters), indicating that pupil size can affect refraction measurements more in this population.

Visual acuity predictions showed that using a 4-mm pupil diameter resulted in fewer letters lost compared to a 6-mm diameter for both groups, suggesting that smaller pupil sizes may provide better visual outcomes in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Pupil Diameter on Objective Refraction Determination and Predicted Visual Acuity. Anderson, HA., Ravikumar, A., Benoit, JS., et al.[2022]

In a study of 57 patients with Down syndrome, 19% were found to have strabismus, primarily esotropia, which was associated with significant refractive errors and anisometropia.

The research highlighted that hypermetropia is more common in patients with strabismus, suggesting that early diagnosis and treatment of these ocular conditions could enhance the quality of life for individuals with Down syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strabismus in Down syndrome. Yurdakul, NS., Ugurlu, S., Maden, A.[2022]

In a study of 222 Japanese children and young adults with Down syndrome, visual acuity (VA) improved with age, indicating a gradual development of vision skills from infancy to late adolescence.

Refractive errors shifted from hyperopia (farsightedness) in infants to myopia (nearsightedness) by junior high school age, highlighting the need for regular eye examinations to identify and correct these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular findings in Japanese children with Down syndrome: the course of visual acuity and refraction, and systemic and ocular anomalies. Terai, T., Eda, S., Sugasawa, J., et al.[2022]

In a study comparing 203 patients with Down syndrome to 189 normal subjects aged 10-30 years, it was found that the total corneal refractive power was significantly higher in the Down syndrome group, indicating a more prolate cornea.

The study also revealed that while corneal astigmatism was similar between the two groups, the prevalence of certain types of astigmatism was higher in the Down syndrome group, and females in this population exhibited a steeper cornea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total corneal refractive power and shape in Down syndrome. Asgari, S., Mehravaran, S., Fotouhi, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Dioptric differences between clinically determined and metric-optimised refractions for adults with Down syndrome. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial of Objective Spectacle Prescriptions for Adults with Down Syndrome: Baseline Data and Methods. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Visual Acuity Outcomes in a Randomized Trial of Wavefront Metric-optimized Refractions in Adults with Down Syndrome. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The accuracy of photoscreening at detecting treatable ocular conditions in children with Down syndrome. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of Pupil Diameter on Objective Refraction Determination and Predicted Visual Acuity. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Strabismus in Down syndrome. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Ocular findings in Japanese children with Down syndrome: the course of visual acuity and refraction, and systemic and ocular anomalies. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Total corneal refractive power and shape in Down syndrome. [2022]