Dilated vs Non-Dilated Eye Exams for Down Syndrome

No longer 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: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if dilating the eyes before a specialized eye exam can improve vision prescriptions for individuals with Down syndrome. People with this condition often experience unique vision issues. The study will compare eye exams with and without dilation (using eye drops to widen the eye). Participants will undergo both methods, known as Dilated Refraction and Non-Dilated Refraction, to identify which provides a clearer vision result. Ideal participants are those with Down syndrome who can undergo eye dilation and focus and respond during vision tests. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both dilated and non-dilated eye exams are commonly used and generally safe for determining eye prescriptions. However, studies have not provided specific safety information for people with Down syndrome (DS).

In a dilated eye exam, eye drops enlarge the pupils, allowing doctors to see more inside the eye. Some people might temporarily experience blurry vision or sensitivity to light. A non-dilated exam skips the eye drops, using the natural pupil size to avoid these side effects, but it might not offer as detailed a view for precise measurements.

The absence of specific safety issues in the research suggests that both methods are generally well-tolerated. Since this trial is in a later phase, earlier research likely addressed any major safety concerns. Always discuss any worries with the trial team to make the best decision about participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of dilated versus non-dilated eye exams for individuals with Down syndrome, aiming to determine which method provides more accurate vision correction. While traditional eye exams often rely on dilation to get precise measurements, this trial investigates whether similar accuracy can be achieved without dilation, which could make the process quicker and more comfortable. By comparing the wavefront measurements obtained before and after dilation, the study could revolutionize how eye exams are conducted for people with Down syndrome, potentially leading to more tailored and efficient vision care.

What evidence suggests that this trial's treatments could be effective for improving vision in individuals with Down syndrome?

Research has shown that using special measurements to determine eye prescriptions can improve vision for people with Down syndrome. In this trial, participants will undergo vision testing with prescriptions based on these measurements. One group will first have measurements taken after using eye drops to dilate the eyes, which relaxes the eye's focusing ability, followed by non-dilated measurements. Another group will start with non-dilated measurements before proceeding to dilated ones. Previous studies indicate that even without dilation, the measurements significantly improved vision by focusing on certain visual aspects. While dilation might provide more precise results, both methods have shown promise in enhancing vision clarity for individuals with Down syndrome. ^{1 2 3 4 5}

Who Is on the Research Team?

Heather Anderson, OD, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo vision testing with prescriptions determined from wavefront measurements, both dilated and non-dilated.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34882603/

Visual Acuity Outcomes in a Randomized Trial of ... Methods: Thirty adults with Down syndrome had a clinical refraction determined by a single expert examiner using pre-dilation and post-dilation ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05059041

Study Details | NCT05059041 | Dilated Versus Non- ... The proposed research evaluates the use of objective wavefront measurements that quantify the HOAs of the eye as a basis for refractive correction ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8720070/

Visual Acuity Outcomes in a Randomized Trial of ... This study reports visual acuity outcomes from a clinical trial investigating an objective refraction strategy that may provide a useful tool for practitioners.

4. withpower.com withpower.com/trial/phase-3-refractive-errors-9-2021-06bf6

Dilated vs Non-Dilated Eye Exams for Down Syndrome In a study involving 30 adults with Down syndrome, objective refractions using wavefront aberration measures provided visual acuity outcomes comparable to ...

5. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2775666

Visual Acuity Outcomes in a Randomized Trial of Clinically ... Purpose : Determining refractive corrections for individuals with Down syndrome (DS) is challenging due to the presence of elevated refractive error, ...