1.1 What is IOLResearch?
IOLResearch is an iPadOS and macOS software platform designed to help ophthalmologists and vision researchers collect, organize, explore, descriptively analyze, visualize, and export data for ophthalmic research.
It is intended to support investigator-initiated and academic ophthalmic research involving procedures and optical solutions that provide simultaneous vision—vision at more than one distance without spectacles—including research related to:
Simultaneous-vision intraocular lenses (IOLs) used in cataract surgery or refractive lens exchange.
Multifocal contact lenses for presbyopia.
Refractive surgery techniques designed to increase depth of field (DOFi), including PresbyLASIK, PRESBYOND, and other approaches.
With IOLResearch, researchers can:
Create and organize research datasets.
Define study variables, procedures, visits, and protocol-defined research activities.
Record or import observations and measurements collected under a research protocol.
Use research-oriented psychophysical modules to acquire protocol-defined responses or measurements from research participants.
Organize longitudinal research observations across predefined study visits.
Explore research outcomes using structured datasets and descriptive analyses.
Generate descriptive summaries, tables, and graphical representations to support scientific analysis and publication.
Export research responses, measurements, and datasets for further scientific or statistical analysis.
IOLResearch is intended as a research data-collection, organization, exploration, descriptive-analysis, visualization, and export platform. Its psychophysical modules support the acquisition of protocol-defined research responses or measurements for scientific research activities.
IOLResearch is not intended for diagnosis, screening, prevention, prediction, prognosis, treatment, patient monitoring, treatment selection, or any other individual medical decision-making. Participant-level outputs are research variables and are not intended to be presented or interpreted as clinical findings, diagnostic results, patient-monitoring outputs, or patient-care recommendations.
IOLResearch does not classify an individual's result as normal or abnormal, provide a clinical interpretation, recommend an intervention, or claim clinical equivalence to a regulated clinical instrument.
Regulatory-use notice
IOLResearch has not been specifically qualified or validated by the manufacturer for use as a regulatory clinical-trial system or for generating clinical evidence intended to support regulatory submissions or conformity assessment.
Use in industry-sponsored regulatory clinical investigations, including studies intended to support submissions to regulatory authorities or conformity assessment under medical-device regulations, is outside the currently assessed intended purpose of IOLResearch and would require a separate assessment by the study sponsor and, where applicable, additional validation and regulatory controls.
Researchers and investigators are responsible for determining whether the methods, research procedures, and instruments used in a particular study are appropriate for its scientific objectives and comply with the applicable research protocol, ethical requirements, institutional policies, and local regulations.
IOLResearch does not replace professional clinical judgment, clinical instruments required by a study protocol, or the investigator's responsibility for the design, approval, conduct, analysis, and interpretation of a research study.