Clinical Research Awards

Effectiveness and cost-effectiveness of TORIC intraocular lens implantation in patients with mild astigmatism

M.M. Dickman, MD, PhD. Ophthalmologist 
University Eye Clinic Maastricht UMC+ 
Maastricht University Medical Center+ 

In 2021, Prof. Stephen Kaye, at the Liverpool University Hospitals NHS Foundation Trust, received the ESCRS Clinical Research Award for his investigator-led project entitled: "Modelling the Corneal Microbiome to improve Identification of Pathogenic Microorganisms (“META-COR-2”)

Project Statement: 

Microbial keratitis (MK) is a major cause of blindness. The likely causative microorganism is only isolated in 40% of cases using conventional diagnostic culture (CDC). More sensitive methods such as next-generation sequencing (NGS) increase the detection of microorganisms but are costly and may increase the likelihood of picking up commensal microorganisms. A novel, minimally invasive corneal sampling method using a corneal impression membrane (CIM) enables sampling of both affected and unaffected eyes. 

Research Project: This uses CIM sampling method and NGS processing to improve understanding of the causative organisms in MK through a better understanding of the corneal microbiome in heath and disease. 151 MK participants and 90 healthy control participants will be recruited at St Paul’s Eye Unit (Liverpool, UK). It is hypothesised that NGS will lead to a much higher identification of causative micro-organisms and a greater selective change in treatment compared to CDC.

Objectives: A comparison of identified bacteria obtained from CDC and NGS processing will be made. Microorganisms identified in the eyes with MK will be compared to the control fellow eye and other control groups and subtractive bioinformatic methodology applied to identify the likely pathogenic organism. Comparisons will be made between the microorganisms isolated from the cornea and contiguous sources to identify any possible endogenous sources of infection. A retrospective analysis will be carried out to identify any treatment changes that could have occurred had the NGS results been available to the treating clinician at time points during the MK disease course.  This will greatly facilitate current interpretation of corneal sample results and facilitate potential future use of NGS in routine ophthalmic clinical practice.

In 2019, Dr. Nienke Visser received the ESCRS Clinical Research Award for her investigator-led project entitled: “EPICAT study: Effectiveness of Periocular drug Injection in CATaract surgery - (“EPICAT”)”

“EPICAT” hypothesizes that periocular anti-inflammatory drug delivery at the end of cataract surgery is effective in preventing CME, with better health-related quality of life and improved cost effectiveness compared to standard topical drug delivery. In the research proposal, the EPICAT study design is a European multicentre RCT. Patients scheduled for cataract surgery will be included in the study. The control group will receive topical dexamethasone and bromfenac postoperatively in a tapering scheme. The intervention groups will receive subconjunctival injection of triamcinolone with or without intracameral injection of ketorolac peroperatively. Primary endpoint is central subfield macular thickness (CSMT). Secondary endpoints include incidence of CME, corrected distance visual acuity and cost-effectiveness. An economic evaluation will be performed from a societal and healthcare perspective. Follow-up duration is 12 weeks. Based on the CSMT results of the PREMED study, the estimated sample size is 540 patients. The study will be conducted over a period of 36 months. It is expected that implementation of dropless cataract surgery will improve both patient-reported outcomes and cost-effectiveness of cataract surgery in Europe. Dropless cataract surgery would also alleviate the current burden on homecare organizations. In the Netherlands for example, estimated costs for formal home care, related to cataract surgery, are €28 million per year.

In 2019, Dr. Mayank A. Nanavaty received the ESCRS Clinical Research Award for his investigator-led project entitled: “Monofocal Extended Range of Vision Study - (“MERoV”)”

It is well recognised that a significant minority patients who have had ‘emmetropic’ monofocal cataract surgery can manage to read well postoperatively. A number of factors are recognised to contribute to this including pupillary miosis, residual myopic sphere, against-the-rule astigmatism, spherical aberration and vertical coma. We will use multivariant analysis to identify the relative contribution of each of these factors to unaided postoperative reading ability following routine ‘emmetropic’ cataract surgery with monofocal intraocular lens (IOL). To screen the patients who underwent routine uncomplicated cataract surgery with monofocal IOL to find out the incidence of patients not needing glasses to see 20/40 and 0.2 LogMAR (J4) for distance and near. To analyse these eyes in comparison to other eyes screened to find factors responsible for 20/40 and J4 unaided vision. Surgeons have increasing control of the refractive outcome of cataract surgery such as spherical power, astigmatism, axis and aberrations. This study would have great practical implications, as by controlling these factors patients will achieve enhanced pseudo-accommodation without dysphotopic symptoms and the expense of a premium intraocular lens.

In 2017, Dr. Gary P. Misson received the ESCRS Clinical Research Award for his investigator-led project entitled: “Cataract, age related Macular degeneration and Polarization perception: the “CaMPoL Study” ”

Macular disease is common in the age-range of patients undergoing cataract surgery and a well-known cause of sub-optimal post-operative visual results. This project presents a novel method for determining macular function that depends on the healthy eye’s ability to perceive polarized light using a prototype device (the macular polarization diagnostic: MPD) as a rapid simple diagnostic test for macular health. The CaMPol Study aims to determine if the MPD is clinically useful in determining macular function in the absence/presence of cataract/pseudophakia, and thereafter in (a) predicting post-operative visual outcome and (b) determining macular function in general will be investigated. If proven, the MPD will be an inexpensive, sensitive, quick and easy test of macular function. Apart from its role as a test of early macular disease, it is hoped that the MPD will be an effective predictor of post-operative visual outcome. It will be an effective screener for macular disease both pre-and post-cataract surgery and is well-suited as a diagnostic test in a high-volume clinic setting. Identifying significant preoperative pathology will minimise costs of unnecessary surgery and allow realistic prognostication. Furthermore, the low cost and portability of the device are suited to self-testing of at-risk individuals and use in low/emerging economies.

In 2016, Dr Jan-Willem M. Beenakker received the ESCRS Clinical Research Award for his investigator-led project entitled: “Virtual REfractive Surgery for the Prevention Of Negative Dysphotopsia”

The objective of the vRESPOND study is to uncover the underlying origin of negative dysphotopsia (ND). ND is a condition after cataract surgery which is manifested as a persistent dark shadow in the patients’ peripheral visual field. The vRESPOND study will develop the methodology to build personalized eye-models which can be used to study the exact path of the light through the eye. These analyses aim to link the optical characteristics of the eye with the complaints. Subsequently these evaluations will be used to develop and evaluate a Virtual Refractive Surgery application, based on the same personalized eye-models, for the prevention and treatment of ND.

The novel, patient-specific, eye-models provided by this study can be used for many different future applications in refractive surgery, enabling innovative clinical solutions for diseases which affect the quality of vision.

In 2016, Prof. Joaquim Murta received the ESCRS Clinical Research Award for his investigator-led project entitled: “NEuroadaptation after Cataract and Refractive SUrgery Study - NECSUS”

The NECSUS study objective is to discover the association between patient reported subjective difficulties and functional magnetic resonance outcomes, independently of optical parameters and psychophysical performance. Dysphotopsia (glare, halos, and starbursts) remain an important cause of dissatisfaction after cataract surgery and a drawback to the more widespread use of multifocal lenses. Cortical processing of these unwanted effects remains unclear and it is necessary to bridge the gap between symptoms and their cortical processing. The NECSUS study will focus on the activity of cortical areas dedicated to attention, learning, cognitive control and to task goals in patients who recently had cataract surgery with multifocal intraocular lens implantation. Such information will provide valuable knowledge on the identification of therapeutic targets and of intraocular lens characteristics that are more likely to trigger neuroadaptation circuits effectively and, hence, lead to practical clinical use for better medical and surgical outcomes.

In 2016, Prof. Dr. Oliver Findl received the ESCRS Clinical Research Award for his investigator-led clinical trial entitled: “Influence of posterior vitreous detachment on retinal detachment after lens surgery in myopic eyes: MYOpic Pseudophakic REtinal Detachment – MYOPRED study”.

The aim of the MYOPRED study is to determine the influence of pre-operative and postoperatively developed posterior vitreous detachment (PVD) on the occurrence of retinal detachment (RD) in myopic patients.
Phacoemulsification with implantation of posterior chamber lenses represents the gold standard of care for patients needing lens surgery, but there is an increased risk of developing pseudophakic retinal detachment after surgery, especially in myopic eyes. In the recent literature, the association between the occurrence of PVD and RD after lens surgery is well documented but hitherto not described for myopic patients.

This multicentre cohort study will include 618 patients scheduled for lens surgery with an axial length of at least 25.0 mm. Patients will be allocated into two groups preoperatively, depending on whether an complete PVD is present or not.
The results of this study will contribute to a higher patient safety level, as cataract surgeons will be able to better inform future myopic patients pre-operatively about their individual risk profile for occurrence of RD after lens exchange surgery.

In 2013, Prof. Mats Lundström received the ESCRS Clinical Research Award for his investigator-led project entitled: “Including patient-reported outcome measures in the EUREQUO database”.

The EUREQUO project, familiar to many of our members, has been very successful in collecting data on cataract surgery outcomes and includes data on four different areas: visual outcome, refractive outcome, complications and patient-reported outcomes.  The existing EUREQUO database includes the first three areas but does not yet contain data on patient-reported outcomes.  An optimal strategy to measure patient-reported outcome is through the use of questionnaires developed and tested to the highest levels of validity. The aim of the 2013 Award project is to offer surgeons and scientists an opportunity to link patient-reported outcome measures to clinical outcome data. This will enable better knowledge of indications for surgery and offer a tool for clinical improvement work based on the patients’ outcome. 

The proposed concept will add an extension to the EUREQUO project to collect the subjective surgery outcome data based on a patient survey for each set of objective surgery outcome data in the EUREQUO DB and will cover a diverse set of EU populations and languages.

In 2012, Dr. Rudy MMA Nuijts received the ESCRS Clinical Research Award for his investigator-led clinical trial entitled: “PREvention of Macular EDema after cataract surgery: PREMED study”.

The objective of PREMED study is to evaluate the effect of different preventive strategies on the occurrence of macular edema after cataract surgery in non-diabetic and diabetic patients. Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been attempted to address the problem of CME after cataract surgery however, no randomised controlled clinical trial has compared all the currently existing interventions and no study has been conducted to investigate whether combining treatments has an additional effect. The PREMED study comprises a large randomised clinical trial (RCT) with the aim of providing more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes.

The outcomes of this RCT will be of benefit to all ESCRS members and cataract surgeons.