2.1 How data is organised

IOLResearch organises study data into five connected elements:

Database → Subject → Procedure (by Protocol) → Follow-up → Result

A protocol is associated with a procedure and defines how the measurement must be performed.

Study data in IOLResearch is related as follows:

• Subject: a participant in the study (created with pseudo-ID, sex, year of birth, and lens/procedure per eye).

• Procedure: a type of assessment performed for a subject (e.g., subjective refraction, visual acuity, defocus curve, CSF).

• Protocol: the configuration that defines how a procedure is performed (e.g., distance, mirror setup, test settings). Protocols ensure consistency across subjects and visits.

• Follow-up: a specific timepoint or visit for a procedure (e.g., preoperative, surgery, day 1, week 1). Follow-ups are where results are stored.

How they connect

• A Subject can have multiple Procedures

• Each Procedure uses one Protocol

• Each Procedure can include multiple Follow-ups

Two types of procedures

• Editable procedures: the user enters the result manually (example: subjective refraction).

• Measurement procedures: the app guides the measurement steps and presents the planned sequence (example: defocus curve with predefined defocus levels).

2.1.1. Database

A database is the main file containing the information for one study, research project, or clinical dataset.

It may contain:

• Subjects and their pseudo-identifiers.

• Demographic information required by the study.

• Intraocular lens assignments.

• Procedures.

• Reusable protocols.

• Follow-up timepoints.

• Measurement results.

Using a separate database for each study or project makes the information easier to manage and reduces the risk of mixing records from different datasets.

Give every database a clear, non-identifying name, such as:

Qvision-01-2026

Avoid including a participant’s name, medical-record number, or another direct identifier in the database name.