An interventional study of PAF (Positioning And Fixation device) in AMD Population - Intermediate or Advanced AMD and DR Population- With or Without Diabetic Macular Edema, sponsored by Notal Vision Ltd.. Completed at 1 site in Israel. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-06-13.
Sponsored by Notal Vision Ltd. · Not applicable, Interventional, and Other
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Among 35 studies in Macular Edema with a site in Israel — 1 open to participants now, 4 under way, 3 of them phase 3. Macular Edema · Israel.
Among the 35 studies in Macular Edema with a site in Israel, this one is the 29th largest by enrollment of the 30 interventional ones that give a count, is one of 2 that started in 2017, is one of 2 with no phase, and was the 14th registered.
757 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
Browse Macular Edema studies →1 of the 35 studies in Macular Edema with a site in Israel is open now. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in Israel, United States, Argentina and 1 more country
Ages 18+
A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →
Of the 44 Macular Edema studies recruiting now, 31 (70%) set no upper age limit and 7 (16%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
35 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 8 · Phase 3 21 · Phase 4 1
First in 2004; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 56 across 585 interventional studies indexed under Macular Edema.
Median enrollment 455 across the 30 interventional studies, 236 across the 5 observational. Of the 29 that completed or were terminated, 22 (76%) have results posted.
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32 of 35 have an industry lead sponsor. The 10 most frequent:
Notal Vision Ltd. is the lead sponsor of 25 studies on the registry; none are open to participants now.
Notal Vision Ltd. has 2 studies filed under Macular Edema — fewer than ten, so there is no comparison to draw.
2 of the studies in Macular Edema with a site in Israel that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07449936Phase 3EyePoint Pharmaceuticals, Inc.COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME | 2027-10 |
| NCT06680817Hoffmann-La RocheA Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) | 2027-06-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 35 studies in Macular Edema with a site in Israel, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of the study "Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging" is to enable self-operation of a monitoring device in home-simulated environment
One of the main challenges in developing a retinal imager is to design it to be self-operated by elderly patients in their home setting The study's objective is to explore ergonomic solutions that will allow the user to perform imaging on their own. The study will be done in a home-simulated environment using a dedicated ergonomic system (termed "PAF" - Positioning And Fixation system) that stimulates the retinal imager and enables to record the tested subject using standard cameras. The prototype doesn't include the retinal imager and does not include any imaging capabilities aside from standard means of photography Subjects will be evaluating for positioning accuracy and comfort by comparing different methods. Pupil position will be recorded using commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: PAF (Positioning And Fixation device)
Up to 60 Subjects will be evaluating for positioning accuracy and comfort by comparing different methods utilizing the PAF device. Some methods of positioning will be applied and compare for each usability factor X, Y, Z location, and fixation. The patient will be evaluated before pupil dilation. VA and ophthalmic diagnoses will be recorded. Pupil position will be recorded using 3 commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images. Each testing session will be limited 20 min long. Subjects will be able to rest within the testing session if required. Total session time per patient will not exceed 30 minutes.
spatial location of the pupil, during an eye examination
documentation of pupil location by a camera
Time frame: 1 year
Ran from Sep 2017 to primary completion in Feb 2018, 4 months.
Of 51 interventional studies with no phase under Macular Edema, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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