Take the next evolutionary step in the daily nAMD challenge with the RetInSight Fluid Monitor

As of April 30th, 2022 the RetInSight Fluid Monitor fulfills all MDR 2017/745 requirements for class IIa medical devices as a Clinical Decision Support System (CDSS) for the monitoring of patients with neovascular age-related macular degeneration (nAMD). It is now available for use in clinical routine and set off the much needed next evolutionary step in the management of patients with nAMD in Europe.

The RetinSight Fluid Monitor is intended to be compatible with all leading OCT systems, starting with the Heidelberg Engineering SPECTRALIS® OCT platform, the Heidelberg Eye Explorer HEYEX image management platform and the Heidelberg Engineering AppWay AI application access solution. 

The RetInSight Fluid Monitor is available for use in the European Economic Area and other countries that accept conformity with European health, safety, and environmental protection standards.

What is the RetInSight Fluid Monitor?

Fluid Monitor is a reliable and accurate AI-based fluid activity meter for the monitoring of disease activity and treatment response in patients with nAMD. It supports the optimisation and personalisation of therapy, with the aim to improve patient outcomes and increase clinical efficiency.

The AI-based software can be deployed by the OCT operator under the supervision of the eye care specialist, producing a concise result report at the click of a mouse, while the patient is on site.​

What does the RetInSight Fluid Monitor do?​1,2

  • It identifies, localises and quantifies retinal fluid in routine OCT images in a fast, objective and precise manner​.
  • It assigns a label to each OCT pixel, denoting its fluid type as intraretinal fluid (IRF), subretinal fluid (SRF) or pigment epithelial detachment-related fluid (PED) when present, as well as its location within the central 1-mm and 6-mm macular area, and provides precise fluid measurements in nanoliters.
  • The distinction of the specific fluid compartments is important because of differences in the impact on visual function and the dynamics of fluid resolution during therapy with different regimens and substances.
  • A detailed analysis demonstrated high accuracy compared to human expert readers and published benchmarks, as well as high reliability at (narrow) 95% CI*​.
1mm6mm
RedIRF77.19 nl368.39 nl
YellowSRF31.9 nl37.05 nl
BluePED60.73 nl595.37 nl

How (fast) are the results presented?

The RetInSight Fluid Monitor provides the whole picture at a glance, in just a few minutes:

  • ​A PDF report showing the fluid type, distribution, quantity and thickness together with the original and annotated images of the central OCT scan for a plausibility check by the eye care specialist.​

By mouse click, while the patient is on site:​

  • Whereas a certified OCT reader needs 2 hours and 49 minutes on average to annotate a conventional OCT volume with 97 B-scans and hundreds of millions of pixels accurately, such as is done during clinical trials for the regulatory approval of novel pharmaceuticals, Fluid Monitor completes this comprehensive analysis in only a few minutes*.
  • In this respect, Fluid Monitor brings clinical trial quality to routine clinical care and thus, helps busy eye care specialists bridge the gap between clinical trial results and real-world outcomes.​

How does it work?

The workflow will vary between the different OCT platforms.​

Which potential value does the RetInSight Fluid Monitor bring?

Eye Care Specialists

  • solid basis for confident treatment decisions
  • The possibility to document the new hard data points facilitates long-term monitoring
  • The ability to optimise and personalise treatment regimens, thereby reducing the risk and deficiencies of over- and under-treatment 2-11
  • A more efficient workflow, resulting in higher patient throughput

Patients

  • Shorter waiting times before getting an appointment with and seeing the eye care specialist
  • Less inconvenience and lower cost associated with travel and absence from work caused by over-treatment, and reduced risk of vision loss caused by under-treatment
  • Increased trust and compliance with the therapy, resulting from receiving an understandable personal Fluid Monitor report as evidence of disease progression and treatment response​

Payer

  • Gaining better insight into the budget spent on nAMD and improving resource allocation
  • Reducing the cost per patient, which, combined with a better patient flow and throughput, results in enhanced patient access 

Hospitals and Clinics

An opportunity to finetune internal treatment protocols, demonstrate quality of care and strengthen the reputation as innovative eye care provider, becoming or remaining:​

  • An attractive and competitive workplace for the AI-generation
  • A preferred eye care provider for patients and referring general practitioners
  • valuable partner to insurance companies and/or Ministries of Health ​

Read in Ocular Surgery News how the RetInSight Fluid Monitor drives breakthrough changes in management of neovascular AMD according to clinical and ophthalmic AI expert Ursula Schmidt-Erfurth.

The RetInSight Fluid Monitor: the new tool to address the nAMD challenge

A heavy disease burden that continues to increase

The Current standard of care for treatment decisions

Using CST as a surrogate biomarker for disease activity

  • Inaccurate fluid representation
  • No segmentation of fluid compartments
  • At best, only moderate correlation with visual acuity

Manual OCT interpretation

  • Less reliable, subjective and qualitative fluid assessment
  • Inefficient workflow
  • Relatively low real-world therapeutic effectiveness
  • Relatively poor (insight into) nAMD budget efficiency

The next evolutionary step

  • Reliable, objective and quantitative IRF and SRF precision measurements by mouse click
  • An AI-based “fluid activity meter” for the optimisation and personalisation of therapy in nAMD
  • Delegable to the OCT operator
  • Closing the gap between clinical trial results and real-world outcomes
  • Improving (insight into) nAMD budget efficiency

About the Fluid Monitor logo​

The RetInSight Fluid Monitor is an AI-based software solution for the detection, localisation and quantification of intraretinal (IRF), subretinal (SRF) and pigment epithelial detachment-related (PED) fluid at an ultrastructural level. This is expressed by the product logos and program icons.

The symbol​

The symbol shows in a graphically abstracted but medically correct way a typical OCT image for retinal fluid. The curved baseline represents the retina; the three ovals represent the fluid compartments embedded in the retinal layers. The waveform indicates the recurrence of fluid, the so-called fluctuations (fluid activity), over the course of the chronic progressive disease.​

The shape​

The basic form of the Fluid Monitor icon is the square. It stands for the therapeutic monitoring. ​

The superscript company logo acts as the sender: Fluid Monitor is a product of RetInSight.

The color​

The basic color dark blue was chosen as an objective, calm and analytical color and one that is associated with trust, honesty and reliability.​

About RetInSight​

RetInSight is the first company to introduce an MDR CE-certified AI-solution for use in clinical routine by eye care specialists. The company was founded in April 2020 as a spin-off from the Department of Ophthalmology & Optometry of the Medical University of Vienna, Austria. RetInSight develops transformational AI-based medical devices and services using OCT images and does this with a clear vision: living longer shall not mean seeing less.

To accomplish this goal, RetInSight develops certified AI-based solutions for therapeutic monitoring and diagnostic screening according to the highest quality standards. RetInSight further owns an extensive library of validated algorithms for use in (bio)pharmaceutical clinical and scientific studies (Clinical Trial Services). Upon certification, these algorithms are made available for use in clinical routine, after already having been applied in large population-based data sets and presented in publications in peer-reviewed journals. In this way, RetInSight helps bridge the gap between superior outcomes observed in clinical trials and inferior benefits obtained at high cost in real life, for the most predominant retinal diseases of our times.​

References

*Data on file RET, submitted for publication​

  1. Pawloff M. et al. “Systematic correlation of central subfield thickness with retinal fluid volumes quantified by deep learning in the major exudative macular diseases.” Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385. PMID: 34934034. ​
  2. Schmidt-Erfurth U. et al. “AI-based monitoring of retinal fluid in disease activity and under therapy.” Progress in retinal and eye research vol. 86 (2022): 100972. 
  3. Oubraham H. et al. “Inject and extend dosing versus dosing as needed: a comparative retrospective study of ranibizumab in exudative age-related macular degeneration.” Retina. 2011 Jan;31(1):26-30. doi: 10.1097/IAE.0b013e3181de5609. PMID: 20890246.​
  4. Kiss S. et al. “Management and Outcomes for Neovascular Age-Related Macular Degeneration: Analysis of United States Electronic Health Records.” Ophthalmology. 2020 Sep;127(9):1179-1188. doi: 10.1016/j.ophtha.2020.02.027. Epub 2020 Feb 28. PMID: 32345477.
  5. Chakravarthy U. et al. “Association between visual acuity, lesion activity markers and retreatment decisions in neovascular age-related macular degeneration.” Eye 34, 2249–2256 (2020). https://doi.org/10.1038/s41433-020-0799-y​
  6. Okada M. et al. “Nonadherence or Nonpersistence to Intravitreal Injection Therapy for Neovascular Age-Related Macular Degeneration: A Mixed-Methods Systematic Review.” Ophthalmology. 2021 Feb;128(2):234-247. doi: 10.1016/j.ophtha.2020.07.060. Epub 2020 Aug 5. PMID: 32763265; PMCID: PMC7403101.​
  7. Boulanger-Scemama E. et al. “Ranibizumab for exudative age-related macular degeneration: A five year study of adherence to follow-up in a real-life setting.” J Fr Ophtalmol. 2015 Sep;38(7):620-7. doi: 10.1016/j.jfo.2014.11.015. Epub 2015 Apr 23. PMID: 25913443.​
  8. Berdeaux et al. “Vision-related quality of life in patients suffering from age-related macular degeneration.” American journal of ophthalmology. 139. 271-9. 10.1016/j.ajo.2004.09.028.​
  9. Cruess A.F. et al. “Economic burden of bilateral neovascular age-related macular degeneration: multi-country observational study.” Pharmacoeconomics. 2008;26(1):57-73. doi: 10.2165/00019053-200826010-00006. PMID: 18088159.​
  10. Brown M.M. et al. “SOCIETAL COSTS ASSOCIATED WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION IN THE UNITED STATES.” Retina. 2016 Feb;36(2):285-98. doi: 10.1097/IAE.0000000000000717. PMID: 26428606. 
  11. Curtis L.H. et al. “Treatment patterns for neovascular age-related macular degeneration: analysis of 284 380 medicare beneficiaries.” Am J Ophthalmol. 2012 Jun;153(6):1116-24.e1. doi: 10.1016/j.ajo.2011.11.032. Epub 2012 Feb 8. PMID: 22321802.​

Clinical Decision Support System (CDSS)

The RetInSight Fluid Monitor is a fully automated comprehensive AI-based Clinical Decision Support System, consisting of:​

  • The artificial intelligence software​
  • The web-based customer portal​
  • The Instruction for Use in the required languages​
  • The secure cloud-based image analysis server​
  • The secured data exchange via internet connection​
  • The cloud-based web service for back-end data storage and maintenance​
  • Compliance with the current EU medical device regulation ​
  • Customer support​

As a CDSS, the RetInSight Fluid Monitor facilitates decision-making in patient management, but it does not provide an autonomous recommendation.

How to get access to the RetInSight Fluid Monitor?

If you would like to receive a purchase agreement for Fluid Monitor, please fill out this short form with your contact details and we will be in touch.

If you have other questions, please contact us.

We look forward to hearing from you.