Table 1.
Consensus Statements Related to Current Limitations Associated with Existing Preoperative Cataract-Refractive Diagnostic Devices
| Topic (Statement Number) | Consensus Statements | Mean | Median | Mode | SD | Range | Level of Agreement |
|---|---|---|---|---|---|---|---|
| Measurement Accuracy and Validation (1) | ”Many aspects of preoperative cataract-refractive evaluation do not meet surgeon needs or have room for improvement.” | 4.1 | 4 | 4 | 1.1 | 1–5 | 85% |
| Measurement Accuracy and Validation (2) | “Two or more devices are needed to measure corneal shape (keratometry, topography, etc.) for managing cataract-refractive patients.” | 4.4 | 5 | 5 | 1.1 | 1–5 | 85% |
| Measurement Accuracy and Validation (3)a | “If there is disagreement of magnitude and/or axis of astigmatism between devices, I feel less comfortable prescribing a toric IOL, and/or this requires further discussion with the patient.” | - | - | - | - | - | 100% (n=13/13) |
| Measurement Accuracy and Validation (4) | “Despite biometry improvements from Scheimpflug and SS-OCT innovation, motion artifact is still preventing companies from developing devices that provide highly accurate measurements of the posterior corneal astigmatism and total corneal topography” | 3.9 | 4 | 4 | 0.8 | 2–5 | 77% |
| Measurement Accuracy and Validation (5) | “One of the common reasons keratometry and topography axes disagree between devices is because separate devices cannot account for difference in patient head alignment between one another during measurement capture.” | 4.2 | 4 | 4 | 0.6 | 3–5 | 92% |
| IOL Power Prediction Formulas (6) | “Approximately 5% to 15% of patients have atypical eyes that are difficult to accurately model using existing IOL power prediction formulas, which increases the likelihood of unpredictable refractive outcomes; therefore, new approaches to IOL power prediction calculations are needed.” | 4.3 | 4 | 4 | 0.5 | 4–5 | 100% |
| IOL Power Prediction Formulas (7) | “Today’s IOL power prediction formulas are still unable to account for every patient-specific variable that can impact the predictability of the refractive outcome, especially in atypical eyes” | 4.6 | 5 | 5 | 0.5 | 4–5 | 100% |
| IOL Power Prediction Formulas (8) | “Patient visual outcomes may be impacted by not accurately assessing pre-op lens and post-op IOL tilt.” | 4.3 | 4 | 4 | 0.6 | 4–5 | 92% |
| Workflow (9) | “Because of the need to get accurate outcomes when implanting premium IOLs today, multiple preoperative devices are required in order to provide a comprehensive preoperative cataract-refractive evaluation before premium IOL decisions can be made.” | 4.7 | 5 | 5 | 0.5 | 4–5 | 100% |
| Workflow (10) | “Measurement inaccuracy that impacts refractive outcomes can lead to patient dissatisfaction, longer chair-time, additional follow-up visits, and lost revenue opportunities.” | 4.8 | 5 | 5 | 0.4 | 4–5 | 100% |
| Technician Skill and Training (11) | “Technicians’ skills vary across facilities, and approximately 25 hours of training is needed per technician for cataract-refractive evaluation practice.” | 3.8 | 4 | 4 | 0.4 | 3–4 | 83% |
| Technician Skill and Training (12) | “Technicians require approximately 5 hours of training per year to maintain competency in using all devices to complete a preoperative cataract-refractive evaluation.” | 4.2 | 4 | 4 | 0.4 | 4–5 | 100% |
| Technician Skill and Training (13) | “Subjective refraction requires a lot of training and motivation of the technicians to learn this skill to a high standard. As a result, many practices who rely on technicians for subjective refraction will be documenting inaccurate postoperative refractive outcomes.” | 4.1 | 4 | 4 | 0.7 | 3–5 | 77% |
| Surgical Planning (14) | “Existing preoperative cataract-refractive diagnostic devices do not allow surgeons to confidently provide a prediction of subjective patient satisfaction.” | 4.3 | 4 | 5 | 0.7 | 3–5 | 83% |
| Surgical Planning (15) | “Inability to predict who will experience dysphotopsias limits a surgeon’s ability to set expectations with patients.” | 4.5 | 5 | 5 | 0.5 | 4–5 | 100% |
| Workflow and Device Features (16) | “Top limitations that cataract-refractive surgeons may face by replacing multiple preoperative cataract-refractive diagnostic devices with a single all-in-one device include cost, device downtime, and adjustment for staff.” | 4.1 | 4 | 4 | 0.3 | 4–5 | 100% |
| Workflow and Device Features (17) | “Top aspects of an all-in-one device that would make cataract-refractive surgeons hesitant to purchase one include cost, dependency on one device, and concerns about quality and accuracy of measurements.” | 4.4 | 4 | 4 | 0.5 | 4–5 | 100% |
Note: aYes/no dichotomous response.
Abbreviations: SD, standard deviation; SS-OCT, swept-source optical coherence tomography.