Fixation Training for Macular Degeneration

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Eye Institute (NEI)

Disqualifiers: Retinal diseases, Cataracts, others

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

Compensation: Varies

Number of Visits: 5

30 Participants Needed

Trial Summary

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fixation training for macular degeneration?

Research shows that improving fixation stability (the ability to keep your eyes steady) is linked to better visual acuity (sharpness of vision) in people with macular diseases. This suggests that fixation training could help improve vision by enhancing fixation stability, which is important for low-vision rehabilitation. ^{1 2 3 4 5}

How is fixation training treatment different from other treatments for macular degeneration?

Fixation training for macular degeneration is unique because it focuses on improving the stability and location of eye fixation, which is crucial for vision rehabilitation, rather than directly treating the underlying disease. This approach is different from other treatments that might focus on slowing disease progression or improving vision through medication or surgery. ^{3 4 6 7 8}

What is the purpose of this trial?

People with central vision loss almost all have exaggerated fixational eye movements when compared with people with normal vision (e.g. larger amplitudes of microsaccades and ocular drifts). Central vision loss primarily results from eye diseases or disorders that affect the macular region of the retina, such as age-related macular degeneration (AMD) and Stargardt disease. The clinical wisdom is that exaggerated fixational eye movements are detrimental to vision. This forms the basis of the increasing number of clinical trials that use fixation stability (variability of eye positions during fixation) as an outcome measure to evaluate the effectiveness of interventions on age-related macular degeneration or other retinal diseases, despite the lack of causal evidence supporting or refuting a relationship between fixational eye movements and functional vision. If excessive fixational eye movements are indeed detrimental to vision for people with central vision loss, can we reduce the amount of their fixational eye movements, thus improve their fixation stability? And if so, does that lead to improved functional vision? The goal of this study is to examine the hypothesis that retinal image motion due to abnormal fixational eye movements can be modified through fixation training, with accompanied improvements in functional vision as a result.

Eligibility Criteria

This trial is for individuals with central vision loss, often due to conditions like age-related macular degeneration (AMD) or Stargardt disease. Participants should have abnormal fixational eye movements compared to those with normal vision.

Inclusion Criteria

I am 18 or older with normal vision, minimal cataracts, and no retinal diseases.

I am over 18, have a macular disorder in both eyes, with a vision of 20/400 or better in one eye, and minimal cataracts.

Exclusion Criteria

I am under 18 with vision issues not corrected to 20/20, have mild cataracts or worse, poor contrast sensitivity, stereoacuity over 40 seconds of arc, or any retinal disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo fixation training to modify fixational eye movements, consisting of 5-6 sessions of training (about 1 hour each).

5-6 weeks

5-6 visits (in-person)

Follow-up

Participants are monitored for changes in fixation stability and functional vision after training.

4 weeks

Treatment Details

Interventions

• Fixation training

Trial Overview The study tests whether fixation training can reduce exaggerated fixational eye movements in people with central vision loss, potentially improving their visual performance and stability of gaze.

Participant Groups

Group I: Microsaccade adaptation Experimental Treatment 1 Intervention

A fixation target will be presented at the center of the display and participants will be asked to keep the target visible at all time. The investigators will measure participants' fixational eye movements continuously and when a microsaccade (small fast eye movements that occur during fixation of a visual target) is detected, the fixation target (a small dot) will jump to a different location, depending on whether the training is to adapt the microsaccades to have smaller or larger amplitudes. With trials, participants would automatically correct for the spatial errors and thus adapting their microsaccade amplitudes. Training consists of 5-6 sessions of training (about 1 hour each). These training sessions will be scheduled weekly if possible, but it is alright if the sessions are not exactly weekly.

Who Is Running the Clinical Trial?

National Eye Institute (NEI)

Lead Sponsor

Trials

572

Recruited

1,320,000+

References

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

Fixation stability as a goal in the treatment of macular disease. [2016]

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

Investigating unstable fixation in patients with macular disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Identification of fixation location with retinal photography in macular degeneration. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Fixation stability using radial gratings in patients with age-related macular degeneration. [2022]

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

Fixation control before and after treatment for neovascular age-related macular degeneration. [2022]

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

Fixation characteristics of patients with macular degeneration recorded with the mp-1 microperimeter. [2022]

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

Stargardt Macular Dystrophy: Changes in Fixation When Asked to Look Straight Ahead. [2019]

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

Fixation patterns and reading rates in eyes with central scotomas from advanced atrophic age-related macular degeneration and Stargardt disease. [2022]