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. 2023 Jul 24:17:2109-2124.
doi: 10.2147/OPTH.S412847. eCollection 2023.

The Current Burden and Future Solutions for Preoperative Cataract-Refractive Evaluation Diagnostic Devices: A Modified Delphi Study

Affiliations

The Current Burden and Future Solutions for Preoperative Cataract-Refractive Evaluation Diagnostic Devices: A Modified Delphi Study

Bonnie An Henderson et al. Clin Ophthalmol. .

Abstract

Purpose: To obtain consensus on the key areas of burden associated with existing devices and to understand the requirements for a comprehensive next-generation diagnostic device to be able to solve current challenges and provide more accurate prediction of intraocular lens (IOL) power and presbyopia correction IOL success.

Patients and methods: Thirteen expert refractive cataract surgeons including three steering committee (SC) members constituted the voting panel. Three rounds of voting included a Round 1 structured electronic questionnaire, Round 2 virtual face-to-face meeting, and Round 3 electronic questionnaire to obtain consensus on topics related to current limitations and future solutions for preoperative cataract-refractive diagnostic devices.

Results: Forty statements reached consensus including current limitations (n = 17) and potential solutions (n = 23) associated with preoperative diagnostic devices. Consistent with existing evidence, the panel reported unmet needs in measurement accuracy and validation, IOL power prediction, workflow, training, and surgical planning. A device that facilitates more accurate corneal measurement, effective IOL power prediction formulas for atypical eyes, simplified staff training, and improved decision-making process for surgeons regarding IOL selection is expected to help alleviate current burdens.

Conclusion: Using a modified Delphi process, consensus was achieved on key unmet needs of existing preoperative diagnostic devices and requirements for a comprehensive next-generation device to provide better objective and subjective outcomes for surgeons, technicians, and patients.

Keywords: IOL power prediction; cataract surgery; measurement accuracy and validation; next-generation diagnostic device; surgical planning.

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Conflict of interest statement

BH, JA, RV, AA, JB, KGG, SG, PG, SM, DR, GS, HJS, and LW are consultants for Alcon Laboratories, Inc. JA reports personal fees from Johnson and Johnson and Staar Surgical, outside the submitted work. AA reports use of equipment by his department from Haag Streit, Oculus, and Zeiss, outside the submitted work. JB reports consultant and/or lecture fees from AbbVie, Aerpio, Alcon, Aldeyra, Aurea Medical, Aurion Biotech/CorneaGen (with ownership), Bausch and Lomb, Dakota Lions Eye Bank, Elios Vision INC, Equinox (with ownership and patents), Expert Opinion (with ownership), Glaukos, Gore, Imprimis (with patents/royalty), Interfeen (with ownership), iRenix, Iacta Pharmaceuticals, JNJ, Kala, Kedalion, MELT Pharmaceuticals, MicroOptx, New World Medical, Ocular Surgical Data (with ownership), Ocular Therapeutix, Omega Ophthalmic (with ownership), Orasis, Oyster Point, RxSight, Santen, Sight Sciences, Surface Inc, Tarsus, Tear Clear, Vertex Ventures, ViaLase, Vittamed, Vance Thompson Vision (with ownership), Verana Health, Versea Biologics, Visionary Ventures, Visus, and Zeiss (with ownership), outside the submitted work. PG reports personal fees from Bausch + Lomb, Carl Zeiss, and Novartis. SM reports personal fees from EyeDx. GS reports grants from Fondazione Roma, Italian Ministry of Health, during the conduct of the study; personal fees from Alcon, Staar, Zeiss, and Johnson & Johnson, outside the submitted work. LW reports personal fees from AcuFocus, Carl Zeiss Meditec, and Cassini Technologies, outside the submitted work. MAG, NF, EP, and WZW are employees of EVERSANA Life Science Services and consult for Alcon Laboratories, Inc. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Schematic of the modified Delphi method utilized in the study.
Figure 2
Figure 2
Illustration of the multi-point Likert scales utilized to assess consensus.
Figure 3
Figure 3
Future innovation needs related to preoperative cataract-refractive diagnostic technologies and IOL calculation methods.

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