Q&A: Updating standards for collecting, reporting outcomes of lens-based surgery
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A guest editorial published in the Journal of Cataract & Refractive Surgery provided updated criteria for collecting, analyzing and reporting the outcomes of lens-based refractive surgery.
The advances in IOL technology in recent decades and the increasing demand for enhanced monofocal, extended depth of focus and multifocal IOLs call for new standards “to include distances other than far distance for efficacy, secondary endpoints and patient-reported outcomes,” the authors wrote.
Healio/OSN spoke with Filomena J. Ribeiro, MD, PhD, one of the editorial authors, to clarify the objectives and summarize the main points of the consensus project.
Healio/OSN: In your editorial, you explain that standard criteria for evaluating the outcomes of IOLs are lacking. Why is standardization important?
Ribeiro: Generally speaking, standardization is highly important in any kind of research and is the basis for evidence-based clinical care. As a first step toward having comparative information, we need to standardize the testing methods and the criteria for reporting our results in clinical studies. The standardization of testing and reporting methods in clinical studies should also consider the possibility of including them in systematic reviews and meta-analyses.
More specifically, for a correct evaluation of lens results with the aim of also correcting presbyopia, we need to report for different working distances and not just for far vision. If we do not do this, we will lose relevant information for comparing results, but above all, we will lose relevant information regarding the functional vision of our patients.
Healio/OSN: How did you and your colleagues work on this consensus paper?
Ribeiro: This project was mentored by Dr. Joaquín Fernández, who gathered a group of experts to reach a consensus for the publication of this editorial.
Healio/OSN: How should visual acuity outcomes be evaluated, taking into account the variety of IOL optics in use today?
Ribeiro: Currently, we have up-to-date resources available that any researcher should know and comply with whenever possible to report results in refractive surgery with implantation of IOLs, including toric IOLs. In the case of multifocal IOLs, the main differences are not in far distances but in intermediate and near distances. Distance corrected near and intermediate visual acuity should always be included instead of corrected near or intermediate visual acuity. In studies with a sufficient sample size to allow age-stratified sub-analysis, efficacy should be reported separately, considering a cut-off age of 65 years or older.
Differences can be found between studies depending on the test distance for which refraction was obtained. Authors should correct the manifest refraction at infinity regardless of the distance used for test refraction (eg, 0.25 D for a 4 m chart distance).
Healio/OSN: What criteria should be adopted to evaluate safety?
Ribeiro: The safety section should include the preoperative and postoperative mean corrected distance visual acuity (CDVA) and the percentage of eyes in which the postoperative CDVA was worse than the preoperative in a 0.2 logMAR difference with the possible causes. International standards also consider including subject-by-subject analysis of reasons if a subject failed to achieve 0.3 logMAR for CDVA.
Healio/OSN: Loss of contrast sensitivity is a specific potential side effect of advanced-technology IOLs. How should it be measured?
Ribeiro: Measurement of contrast sensitivity with multifocal IOLs should be conducted, correcting the vergence induced by the test distance and preferably in monocular vision with manifest refraction for detecting the loss of contrast that may be associated with the lens.
Healio/OSN: Is there a tool that is better than others for obtaining clinically relevant information on patient satisfaction, spectacle independence and comfort in carrying out daily activities?
Ribeiro: Subjective evaluation through patient-reported outcomes measures should be encouraged to allow for this analysis. Unfortunately, there is no validated questionnaire that covers all the clinically relevant domains for patients implanted with presbyopia-correcting IOLs. Currently, we can only choose the validated questionnaire that better fits the domain that we intend to measure. In addition, we suggested reporting the percentage of patients who achieved spectacle independence at distance, intermediate and near in the short, medium and long term, the percentage of patients complaining of photic phenomena and the percentage of patients who would choose the same IOL again.
Healio/OSN: What other parameters may be important to consider?
Ribeiro: Including the correlations between pupil diameter and visual performance can help the reader to understand the pupil dependence of specific presbyopia-correcting IOLs.
Reference:
- Fernández J, et al. J Cataract Refract Surg. 2022;doi:10.1097/j.jcrs.0000000000001013.
For more information:
Filomena J. Ribeiro, MD, PhD, of Hospital da Luz, Lisbon, Portugal, can be reached at filomenajribeiro@gmail.com.
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