ClinicalTrials.gg
CompletedNCT03374020Updated Nov 13, 2020

Retinal Imaging Using NOTAL-OCT

An observational study in Age-Related Macular Degeneration and Diabetic Retinopathy, sponsored by Notal Vision Ltd.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Notal Vision Ltd. · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
33
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 26 studies in Macular Degeneration by Notal Vision Ltd. — none open to participants now, 1 under way, none of them phase 3. Macular Degeneration · Notal Vision Ltd..

Planned enrollment
14th of 25
33 · median 42
Started
2017
with 1 other
Observational
25 of 26
none open now
Registered
20th of 26
by date

Among the 26 studies in Macular Degeneration by Notal Vision Ltd., this one is the 14th largest by planned enrollment of the 25 observational ones that give a count, is one of 2 that started in 2017, is one of 25 observational ones, and was the 20th registered.

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

Browse Macular Degeneration studies →

Open to participants now

None of the 26 studies in Macular Degeneration by Notal Vision Ltd. is open now. The open studies under Macular Degeneration, anywhere →

Where they have run

Who these studies take

Of the 166 Macular Degeneration studies recruiting now, 117 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 26 studies in Macular Degeneration by Notal Vision Ltd. as a file.
02

Study summary

Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)

03

Conditions studied

  • Age-Related Macular Degeneration
  • Diabetic Retinopathy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  1. AMD population - intermediate and advanced AMD (with active and non-active CNV)
  2. DR population. Patient with and without DME

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability and agreement to give (IC)
  2. Diagnosis of AMD or DR in SE by OCT
  3. Ability to undergo OCT scans
  4. VA of 20/160 or better in SE

Exclusion criteria

Exclusion Criteria:

  1. AMD and DR in the same SE
  2. Evidence of macular disease other than AMD or DME in SE
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
33 participants (estimated)
Patient registry
No

Groups and cohorts

  • Intermediate AMD

    Device: Notal OCT

  • Advanced AMD

    Device: Notal OCT

  • DR without macular edema

    Device: Notal OCT

  • DR with macular edema

    Device: Notal OCT

Interventions

  • DeviceNotal OCT

    Imaging using Notal OCT

06

What researchers measure

Primary outcomes

  1. The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.

    OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision "there is fluid" or "there is no fluid" will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in May 2018, 15 months.

Of 56 industry-sponsored observational studies under Macular Degeneration, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 69. This study's 15 months is below that.

Counting every sponsor, half of 161 studies reached it within 45 months; a quarter within 16 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Dec 14, 2017
StartActual
Jan 17, 2017
Primary completionActual
May 14, 2018
CompletionActual
Dec 1, 2018
Last update
Nov 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03374020
Lead sponsor
Notal Vision Ltd.
Responsible party
Sponsor
First posted
Dec 14, 2017
Start date
Jan 17, 2017
Primary completion
May 14, 2018
Completion
Dec 1, 2018
Last update
Nov 13, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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