Thank you for your interest in the LUMA Study (Light-deprivation Utilized to Mitigate Amblyopia) of the State University of New York College of Optometry (SUNY-Optometry).
The following text describes:
- Who can apply to participate (“eligibility”)
- Application process
- Purpose of the study
- What participants will do during the study
- Important questions and answers
The LUMA Study will require an unusually high level of commitment from participants. The study lasts for 15 months, including up to 10 days in the dark at our off-site residential study location and 8 weeks of 45-minute vision training homework, 5 days a week. Participants will be paid a stipend of $100 per day for the sequestration portion of the study if they are chosen. They will also be compensated for vision training homework at the rate of $10 per day, and for any visual, psychological, or physical examinations required at the rate of $15 or $20 per visit, depending on the type of visit. After you read about the study, if you are still interested in participating, we would like to hear from you.
1. Who can apply to participate (eligibility)?
To be eligible for this study, you must meet all of these criteria. You must:
- Be 18 years of age or older
- Have been told by a medical/eye care professional you have amblyopia (“lazy eye”) due to anisometropia (decreased vision in one eye due to difference in prescription between your two eyes). You must have 20/25 visual acuity or better in your dominant eye, and visual acuity of between 20/30 and 20/400, even with glasses on, in the other eye.
- Have no history of strabismus (eye turn). Many amblyopes have strabismus. If you ever had strabismus, or if you ever had eye surgery, you are ineligible for this study because it will not include treatment for binocular eye movements.
- Note: if you do have a history of strabismus, we would be keen to know about you for possible future studies. Please use this form to tell us about yourself.
- Be willing and able to
- Spend up to 10 days sequestered in complete darkness with up to three other participants. Being sequestered means that you will not be able to leave the research site or have face-to-face contact with people outside (see part 4(II) below).
- Do vision training (video game playing and/or computer vision tests) on your own for 45 minutes per day, five days a week, for 8 weeks.Make regular visits to SUNY-Optometry (33 W. 42nd St., New York, NY) for comprehensive visual testing and brain scans over the course of 15 months. Visual testing at SUNY-Optometry varies in frequency during the study.
- Complete two physical exams with accompanying blood draws for research and screening purposes.
- Not be currently taking medicines for seizure, anxiety, depression, or any mental illness, nor taking medicines (such as eye drops or injections) that would be difficult to administer without vision.
- Be in good physical and mental health.
- Pass a criminal background check.
- Have your own health insurance
2. Application process
Prospective participants must:
- Meet eligibility requirements
- Complete and submit the full application
- Pass a quick (20 minute) visual screening evaluation at SUNY-Optometry
- Undergo a complete visual examination and personal interview at SUNY-Optometry
- Pass a criminal background check
- Be selected for participation by our admissions panel
- Read, understand, and sign the study’s participation consent forms
This will be a small study with only 4 people per group. We will try to create well-balanced groups, taking into account age, gender, and severity of amblyopia. As a result, if you are not selected it does not mean that you are a poor candidate for future studies to test amblyopia treatments. Please let us know if you might be interested in participating in future studies.
3. Purpose of the study
The purpose of this study is to understand the effect of total darkness as a way to enhance treatment of human amblyopia. Five or ten days of complete darkness may promote learning in the adult visual system, and allow subsequent visual training treatment for amblyopia to be more effective, although we do not know if or with what likelihood this will result.
As a participant in this study, you will be assigned to one of three experimental groups: five days of visual deprivation, 10 days of visual deprivation, or zero days of visual deprivation (control group). Being sequestered means you will live with a group of up to three other participants like yourself in a special environment set apart from people who are not in the study. After the visual deprivation and sequestration, all subjects will receive daily amblyopia treatment after they come out of sequestration (same treatment for all subjects).
To participate, you must be willing to undergo up to 10 days of visual deprivation (living in completely dark quarters and/or with complete blindfolding). Visual deprivation will be achieved using a darkened facility. You will have a day at the facility before visual deprivation commences to allow you and your fellow participants to become familiar with your surroundings.
It is common for visual deprivation to cause transient visual hallucinations (between the 2nd and 3rd day). These visual hallucinations might be swirling colors or patterns on the walls or floor, or faces, objects, etc. If you are concerned about how you would react to seeing visual hallucinations, you should not apply to participate in this study. We expect that many participants will experience hallucinations during the study.
4. What participants will do during the study
The study will last 15 months. It has four phases:
I. Application, physical and psychological testing, visual examination, and monitoring (4 months)
Participants will apply to participate in the study. If your application indicates that you may be eligible to participate, you may be invited to the SUNY College of Optometry for a quick (20 minute) visual exam to determine whether or not you meet the core visual requirements for the study. If you are found to meet the eligibility requirements, you will receive a full visual examination, and, if necessary, be fitted with new contact lenses or glasses. If you receive new contact lenses or glasses, you must wear them according to instructions, because your vision must be fully adapted to any beneficial effects of the glasses or lenses themselves before Phase II. As you wear your contacts or glasses over the next four weeks, you will have to complete two additional eye exams (one every three weeks) to check the status of your vision. Additionally, a physician will conduct a routine physical examination and blood draw consisting of a CBC (Complete Blood Count) and complete metabolic panel, so we can track any physiological changes that may occur during sequestration (based on a pilot study, no adverse physical effects are expected, however these data may help establish the safety of this experimental therapy for future studies). A series of psychological tests will also be administered by a qualified member of the research team, the results of which will be used to establish psychological suitability for the study and to track any psychological changes if they occur.
II. Sequestration in a special facility with other participants and our staff (0, 5, or 10 days)
If you are assigned to a darkness group, you will arrive at our sequestration facility, which is a converted apartment in Brooklyn with an area set apart for our study. There will be one day of orientation, during which time you will get to know your fellow participants, and be trained by experts on how to navigate safely in complete darkness. After the orientation day, you will start the five or ten day sequestration. You will have some unstructured down time every day during which you can do an independent activity of your choice (such as listening to music, meditating, additional exercise, knitting, etc.); however, individual and group activities will also be scheduled to help structure your time (journaling, exercise, meals, games, entertainment, learning experiences, books on tape, etc.).
You will be given at least 30 minutes a day in a private space to talk with family or friends over the phone, but study participants will not be allowed to keep their phones with them. However, you may keep your phone charged up and on site, and get help from a study coordinator to make calls.
Your activity and sleep habits will be monitored and recorded using a fitness tracker which will be provided for you for the duration of the study, but must be returned at the end of the sequestration time. Additionally, a specially adapted iPod shuffle will be provided to you for personal music or audio that you may wish to listen to during the sequestration period, which will be yours to keep.
At the end of the sequestration period you will be given another vision test at SUNY Optometry (we will provide transportation). You may have a family member or friend accompany you if you like. Additionally, you will be given another routine physical exam including a blood draw at a nearby medical center, and psychological tests to evaluate the quality of your experience during sequestration.
III. Daily vision exercises (8 weeks)
The vision training for all participants lasts 45 minutes per day. It includes playing a video game on a virtual reality headset that we will provide. Part of this time must be spent wearing an eye patch over your better-seeing eye, and part must be spent wearing special glasses to reduce visual contrast. You must come to SUNY Optometry for 8 vision checkups during this period.
IV. Continued follow-up (10 months)
You will be asked to come to the SUNY College of Optometry for 7 scheduled vision checkups during this period. You should not continue using the eye patch or contrast-reducing glasses during this period.
5. Important questions and answers
5(a) What are the risks to me?
If you develop a problem or suffer an injury, you should tell the study staff immediately.
There are three known risks to participants in the study: (1) visual system, (2) psychological, and (3) physical.
(1) Visual system risks: If your visual system becomes more “plastic” (willing to learn), the nerve cells (or neurons) in your visual system may establish new connections that cause your vision to become worse rather than better. This outcome has not previously been reported to occur in animals or humans, but previous studies may not have been adequate to detect and report any such adverse effects. In addition, your amblyopic visual system might respond to the controlled visual experience, or to the visual training you will do after being in the dark, in a different way than a normal visual system would respond, for unknown reasons. There could also be a small percentage of the population that responds negatively and you might be part of that population.
In designing this study, we have taken steps to minimize the risks to you, the participant, to the best of our ability. We know of no reports in which 10 days in the dark was harmful, physically or psychologically. However, we cannot rule out the possibility that one of the following complications could develop in your vision: decrease in visual ability in your amblyopic eye, decrease in visual ability in your better eye, diplopia (double vision), problems with reading comprehension, or a problem with visual-motor coordination or object recognition. These are the problems most likely to develop, if there is a problem, because your brain will be learning to use both of your eyes together in a new way.
As a part of the study, you will have to undergo a total of three full ophthalmic eye exams. In these exams, drops will be put in your eyes to dilate your pupils. The drops may blur your vision and make you sensitive to light. The drops will wear off over several hours. There is a small (less than 1%) risk of an allergic reaction to the drops, which can include temporary stinging, increased eye pressure, nausea, headaches, dry mouth, or irritation. Due to the blurring effect on your vision and possible light sensitivity, we suggest that you do not drive until the drops have worn off. If necessary, have someone come with you who can drive for you after the exam.
If you are fitted with contact lenses by one of our clinical investigators as part of this study, there are contact lens complications that could develop as a result of contact lens wear. These complications may include one or more of the following symptoms: blurred vision, redness, irritation, tearing, discharge, or itching. If these or any other vision problems occur, and cannot be treated expeditiously, your participation in the study may be terminated and you will be followed by clinical staff at the SUNY College of Optometry at no charge to you for up to four weeks, unless we determine that no further treatment will solve the problem.
Please note that we cannot guarantee that a problem that arises unexpectedly will disappear after the study concludes. For example, you could develop double vision that does not resolve or go away even after we have tried to treat it for four weeks. You will be responsible for getting any additional vision treatment that you feel is desirable or necessary after treatment by our study staff is discontinued.
(2) Psychological risks: As a result of an extended period of visual deprivation, there is the likelihood that you will experience visual hallucinations. For example you may see swirling colors or patterns, faces, objects, or scenes. Other researchers have found that a significant fraction of subjects experience temporary visual hallucinations when they are put in a dark environment with a blindfold for hours or days. Your visual system will be reacting to a condition that is not usually experienced by humans. Although these hallucinations are not generally unpleasant or threatening, some people may become anxious or made uncomfortable by this experience. If you think that visual hallucinations would be upsetting to you, you should not be part of this research study.
Other potential risks include: lethargy, anxiety or other mood changes, and discomfort due to lack of normal routine. During sequestration, we will provide both group and individual activities, and exercise, to mitigate these risks, and we will have a licensed social worker or psychologist available for consultation during the study.
You will be able to withdraw from the study if you are experiencing psychological distress or if you wish to do so for any other reason, without forfeiting your right to claim payment for parts of the study completed.
If for any reason we feel it is inadvisable for you to remain in the dark, we may ask you to leave the dark before the end of the 5 or 10-day sequestration period.
Many measures have been taken during the design of this study and will be taken during its execution to ensure that all foreseeable risks are minimized. Psychological tests administered prior to your time in sequestration will help determine your susceptibility to these risks, and if you are found to be prone to adverse psychological effects according to these inventories, you may be asked to leave the study. All subjects will be monitored for adverse effects during all stages of this study, both verbally and by way of clinical assessment. Subjects will be asked to keep a record of all visual disturbances and psychological effects, should they occur.
(3) Physical risks: Certain risks are inherent in being sequestered in complete darkness, and some of these risks differ from the risks normally associated with more traditional clinical studies. These risks include, but are not limited to, physical injury while in complete darkness, including bumps, scrapes, bruises, abrasions as well as more severe temporary or permanent injuries or disabilities. Additionally, living with up to three other people for up to 10 days in a sequestered space may pose the risk of violence or harassment, although many measures will be taken to minimize these risks.
Risks associated to blood drawing include temporary pain and bruising where the needle enters the skin, and sometimes, fainting.
Please be aware that SUNY College of Optometry does not have a comprehensive formal plan or program to provide for costs of medical treatment, psychological treatment, or compensation for any injury, which may occur as a result of your participation. Thus, it is possible that your treatment could be limited, or that you would not be compensated for an injury that results from participation in this study. For this reason, you must have health insurance to participate in this study. If you develop unexpected medical problem(s) during the study we will refer you to an appropriate health care provider, but we will not pay for treatment or care of the problem(s), except as noted in section 5(1) above for visual system disorders.
5(b) How can I minimize the risks to me?
Many measures have been taken during the design of this study to minimize foreseeable risks. All subjects will be monitored for adverse effects during all stages of this study, both verbally and by way of clinical assessment. Subjects will be asked to keep a record of any visual disturbances or psychological effects, should they occur.
If you experience any injuries or adverse effects during any phase of the study, whether they are related to your vision or not, you must alert a member of key personnel on the study staff immediately. Doing so will minimize your risks. You can also minimize risks by participating in the planned activities during sequestration, and by showing up for all visual examinations after the light deprivation portion of the study is complete.
5(c) What are the potential benefits to me?
Your participation may result in the following benefits:
You will receive a full ophthalmic eye exam, and, if needed, new spectacles or contact lenses with the best possible refractive correction. You will undergo an eight week long supervised video-game based vision therapy program for amblyopia. This treatment, based on current research, is expected to provide a modest improvement to your vision no matter which group you are in, but this is not a guaranteed outcome.
If you are assigned to a binocular deprivation condition and your visual system plasticity is successfully increased, your vision may improve more than it would with just the vision therapy treatment, but we do not yet know how likely this is to occur. There is an unknown risk that your vision could get worse.
You will be providing a benefit to other people with amblyopia by helping to test whether new treatments are effective.
5(d) Will I be paid?
You will be paid at the rate of $100 per day for the sequestration portion of the study if you are chosen. This payment will be made at the end of the sequestration period, or at any point when you leave the study. You will also be compensated for vision training at the rate of $10 per daily session (up to $400 total, to be paid in lump sum at the end of the 8 week Vision Therapy period or at any point when you leave the study), $20 for each of the three full ophthalmic exams (up to $60 total, to be paid on the date of each visit) and $15 per visit for any optometric, psychological, or physical examinations required (up to $330 total, to be paid on the date of each visit). In total, you may earn up to $1775 for participating in the study.
Additionally, you will be provided with all meals and lodging during the sequestration period as well as the comprehensive vision exam and a glasses or contact lenses as described in 5(c) above.
5(e) What are the potential benefits to society?
The purpose of this study is to investigate the usefulness of exposure to continuous darkness in the treatment of adult amblyopia. Results from this study may be used for larger scale studies to further improve treatment. If measurable benefits to vision are identified, a treatment that is non-invasive, safe, and faster than other treatments would become available.
5(f) How long will the study take and what is required of me?
If your application indicates that you may be eligible, you will be contacted and invited to come to the SUNY College of Opotmetry for a quick (20-minute) eligibility screening to determine whether or not your vision qualifies you fore the full study. If you are, you will be scheduled for the first part of the full study. The full study begins with a comprehensive eye exam and the prescription of best ophthalmic correction. If you are new to contacts, you will be given instructions on how to you’re your contacts, and additional visits may be required to make sure you are comfortable wearing them. There will be two or more follow up visits during the next 10 weeks. There will be a 0, 5 or 10-day period of sequestration in the dark, followed by the 8 week training period. During the 8 week training period, you must do 45 minutes of visual training 5 days a week (in the form of video game playing), and visit the College of Optometry for a total of 8 short (30 minute) vision check-ups. In the 10 months after the visual training period, you will also be expected to come for 7 more 30-minute follow-up visits at SUNY Optometry. There will also be a total of 3 visually evoked potential (VEP) session conducted at SUNY Optometry, Room 1419. VEP is a non-invasive one-hour procedure that includes attaching sensors to your scalp.
5(g) When will I get to meet the other participants who will be sequestered with me?
You will spend a day before sequestration as a group, in normal lighting and without blindfolds, participating in activities, eating meals, and becoming familiar with your surroundings. You will also learn safety and evacuation procedures, as well as techniques for safe navigation in complete darkness.
5(h) What if I have a medical emergency during the sequestration period?
If at any time you decide that you need to leave the sequestration facility, you will be allowed to do so. Minor medical issues such as scrapes can be treated at the facility, but we will advise you to seek care outside the facility if you have a more serious medical emergency.
5(i) What if I have a family emergency during the sequestration period?
Your commitment to the study is important, but if you have an emergency that requires your personal attention, you may exit the study. Please make contingency plans that would allow a family member or friend to take care of as many unexpected matters as possible. If a family emergency is a likely possibility, then you should not participate in the study.
5(j) May I withdraw from the study at any time?
Yes, your participation is entirely voluntary, and you may withdraw from the study, without penalty, at any time for any reason. If you decide to withdraw from this study at any point, you will be paid for parts of the study you have already completed.
5(k) If I am not selected for, or withdraw from the study, what will happen to the information collected in this application?
Application information (including answers from the application questionnaire, interview notes, criminal background check results, and physical/psychological exam results) for applicants not selected, or participants withdrawing from the study, will be permanently de-identified so that your answers and PHI are no longer associated with you in our records.