NCT06963138

Comparative Study and Validation of New Methodologies for Measuring Addition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Refraction is the key point of an ophthalmic examination when visual correction is required for distance vision, as is determining the addition for near vision. These measurements can be obtained objectively and/or subjectively. The addition for near vision is most often obtained using so-called subjective devices, i.e., by relying on the patient's responses. The state of the accommodative system can, however, be measured objectively using instruments available to prescribers (retinoscopes, automatic refractometers, aberrometers, etc.). These measurements can be used in clinical practice as a solid basis for the initial assessment of the subject's refractive status during a comprehensive eye examination. However, these measurements are not sufficient to determine the optimal correction to prescribe for near vision, i.e., one that achieves sufficient visual acuity and comfort to ensure effectiveness for the tasks a person wishes to perform in their daily life. Indeed, subjective tests are considered the gold standard for prescribers, particularly when it comes to near vision testing. Also, there are numerous procedures for determining the appropriate addition to prescribe, and a wide variety of practices is observed among prescribers around the world. It is often necessary to perform multiple tests to ensure the correct addition value to recommend. The aim of this study is to find ways of approaching the value of the ideal addition as accurately as possible, based on several parameters: measurements representative of subjects' near vision habits, optometric measurements to determine near vision addition, and measurements related to binocular vision and symptomatology. This data collection will enable to identify the most effective combination of measurements in order to determine the optimal near vision addition for a subject.

Conditions

• Presbyopia
• Near Vision
• Refraction Error

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-31
• Primary completion: 2025-05-05
• Completion: 2025-05-05
• First posted: 2025-05-08
• Last updated: 2025-06-06

Locations

1 site across 1 country: France