Comparative Study and Validation of New Methodologies for Measuring Addition

NACompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

March 31, 2025

Primary Completion Date

May 5, 2025

Study Completion Date

May 5, 2025

Conditions
PresbyopiaNear VisionRefraction 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."

Trial Locations (1)

94000

Essilor International - Ci&T 2, Créteil

Sponsors
All Listed Sponsors
lead

Essilor International

INDUSTRY