Clinical Research Awards

Advancements in presbyopia correcting IOL technology offer the potential for spectacle independence in patients with a history of keratorefractive surgery. To assess their effectiveness in meeting the high expectations of this patient population, high-quality research is needed.

The research on the use of presbyopia-correcting IOLs has grown in recent years, as these IOLs may provide spectacle-free vision in patients. However, adoption of these newer IOLs is slower than expected, due in part, to a lack of confidence from surgeons and demand from patients for these technologies.

In the meantime, there is an ever-increasing patient population who could benefit from this category of IOLs – patients who have previously undergone corneal refractive surgery and are now developing cataracts. For these patients, standard monofocal IOLs may not sufficiently address their needs, since these patients have grown accustomed to life without the need for spectacles.

Therefore, there is a clear need to prospectively and objectively evaluate the outcomes of presbyopic-correcting IOLs in post-keratorefractive surgery patients, allowing surgeons to propose evidence-based solutions to patients.

In order to tackle this important topic, ESCRS is seeking applications from European-based ophthalmologists and researchers for an ESCRS-funded trial.

The results of the funded project will:

• Provide objective clinical evidence on the use of presbyopia-correcting IOLs in patients that have previously undergone keratorefractive surgery.
• Establish an independent database of clinical outcomes on presbyopia-correcting IOLs, including guidelines/ preferred practice patterns on optimization of IOL calculation in post-keratorefractive eyes.
• Increase the level of confidence of surgeons towards the use of presbyopia-correcting IOLs.

Eligible applicants must be based in Europe or Brazil. This includes continental Europe including Switzerland, the United Kingdom, Ireland, Turkey, and Israel.

Applicants must hold a full-time clinical/research post at a clinical or academic centre (public or private) in these regions.

An ESCRS membership is not required to apply to the award.

1. (a) I hold a full-time or affiliated post with an established EU-based clinical or research institute named below (EU countries and WHO associated countries).
2. (b) I have demonstrable prior experience in the conduct of clinical research in the field of ophthalmology.
3. (c) I am familiar and experienced with the administrative, insurance and regulatory requirements for the conduct of EU-based clinical research studies.
4. (d) I understand that Expressions-of-Interest will be evaluated by the ESCRS Research Committee (including other independent peer reviewers) who will generate a shortlist of applicants to be invited to make a full comprehensive research proposal. I understand that all decisions on Expressions-of-Interest and/or short-listed proposals made by the ESCRS shall be final and no correspondence will be entered on any matters arising from any the Clinical Research Awards.
5. (e) I confirm that I am the author of the application 

*The study should identify which type of human study to be used: non-interventional study, low intervention clinical trial, observational study, other; is it to use a medicinal product, medical device, diagnostic device. If known, please provide the details, for example, Regulation (EU) No. 536/20141 or Regulation (EU) 2017/745 on Medical Devices (MDR)2, or other (give explanation).

1 Regulation (EU) No. 536/2014 
2 Regulation (EU) 2017/745 on Medical Devices (MDR)

If any of the required information is omitted, an entry will not be evaluated.

Any queries regarding the application form or process should be directed to the Clinical Trials Research team via the ESCRS Secretariat: clinical.research@research.escrs.org 

This preliminary application should be comprised of:

• Title
• Project duration
• Support requested
• Chief investigator and consortium, i.e., a group of clinical centers from one or more EU countries that will submit under one application
• Public summary
• Background
• Objectives
• Project plan (with a Gantt chart)
• Existing infrastructure
• Preliminary budget
• Relevant publications

The expressions of interest will be validated by ESCRS staff and the complete applications will be shared with an external panel of expert topic reviewers that will score and provide expert review on the proposals.

ESCRS staff will consolidate the reviews and rank the proposals accordingly. The results will then be shared with the ESCRS Research Committee which will review and decide on the expressions of interest to be invited for a full proposal.

The top-ranked applications that exceed a score threshold will be invited to submit a detailed proposal.

The full proposal should include:

• CV of chief investigator
• CV of co-applicants
• Study team expertise on similar clinical trials
• Trial management
• Study design:
  • Trial design
  • Statistical considerations
  • Recruitment plan
• Detailed budget