Comparative Study and Validation of New Methodologies for Measuring Addition

Summary

The aim of this research is to collect comprehensive data on a presbyopic population that may require near vision correction, in order to identify the most useful tests to accurately determine the value of an addition.

Conditions

• Presbyopia
• Near Vision
• Refraction Error

Interventions

DEVICE

Visual Acuity

VA will be measured for near and distance vision with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart

DEVICE

Objective refraction

Objective refraction will be measured using an auto-kerato-refractometer/aberrometer

DEVICE

Standard Subjective refraction

Standard subjective refraction for distance vision will be performed with Vision-R™

DEVICE

Near vision examination and determination of additions

Near vision examination and determination of additions will be performed with Vision-R™. The following objective and subjective measurement methods will determine the values of the various additions: 1. Determination of addition using the retinoscopy method (Add\_OBJ) 2. Randomization and administration of addition determination tests: FCC; R/G; PRA-NRA

DEVICE

Binocular vision tests

The following measurements will be taken in trial glasses equipped with the final addition: 1. Stereoscopic acuity measurement 2. Measurement of the Near Point of Accommodation (PPA) 3. Measurement of the Near Point of Convergence (PPC) 4. Measurement of fusion reserves 5. Measurement of prismatic rock 6. Subjective questionnaire on the different methods used

DEVICE

Extended trial of addition

The following measurements will be performed using trial glasses equipped with the final addition: 1. Submission of the CISS questionnaire and distance adaptation 2. Initial measurements of accommodative positioning and phorias 3. Completion of three smartphone tasks: reading, memorization, and video viewing 4. Final measurements of accommodative positioning and phorias 5. Submission of the QoL questionnaire regarding visual discomfort during the trial.

Sponsors & Collaborators

• Essilor International

  lead INDUSTRY

Principal Investigators

• François Daniel · ESSILOR INTERNATIONAL - Division Instruments

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2025-05-05

Completion

2025-05-05

Countries

• France

Study Locations