Comparative Study and Validation of New Methodologies for Measuring Addition

NCT06963138 | Completed

• 2 other identifiers: WS103312023-A00122-43
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Subject's age

  The subject's age is requested via the Case Report Form

  Day 1

• Addition value given by the objective method

  When you have presbyopia, the lens is no longer able to increase its power to accommodate near vision. It must then be helped by adding power for near vision, i.e., increasing the strength of the lens: this is called addition. The value of the addition is expressed in diopters (D) and is automatically measured by an auto-kerato-refractometer/aberrometer. It is an objective measure because it does not call upon the subject's responses when presented with acuity scales.

  Day 1

• Addition value given by the subjective method

  When you have presbyopia, the lens is no longer able to increase its power to accommodate near vision. It must then be helped by adding power for near vision, i.e., increasing the strength of the lens: this is called addition. The value of the addition is expressed in diopters (D) and is automatically measured by an autorefractometer. It is a subjective measure because it calls upon the subject's responses when presented with acuity scales.

  Day 1

• Working distances for near vision

  Several working distances are measured for near vision. The values of the distances are expressed in centimeters (cm). The various working distances for near vision are: * Harmon distance: the morphological distance from the elbow to the clenched fist * Revip distance (visuo-postural reflex): the subject is given a blank A4 sheet of paper and asked to hold it at their potential reading distance. * Desired distance: the distance at which a subject can read a Times 12 text on an A4 sheet of paper.

  Day 1

Secondary Outcomes (2)

• Quality of Vision questionnaire (Qov) score

  Day 1

• CISS questionnaire (Convergence Insufficiency Symptom Survey) score

  Day 1

Study Arms (1)

Validation of new addition measurement methodologies

EXPERIMENTAL

Device: Visual Acuity; Device: Objective refraction; Device: Standard Subjective refraction; Device: Near vision examination and determination of additions; Device: Binocular vision tests; Device: Extended trial of addition

Interventions

Visual Acuity DEVICE

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

Validation of new addition measurement methodologies

Objective refraction DEVICE

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

Validation of new addition measurement methodologies

Standard Subjective refraction DEVICE

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

Validation of new addition measurement methodologies

Near vision examination and determination of additions DEVICE

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

Validation of new addition measurement methodologies

Binocular vision tests DEVICE

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

Validation of new addition measurement methodologies

Extended trial of addition DEVICE

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.

Validation of new addition measurement methodologies

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteer, fluent in French, willing to follow the protocol, able to read and understand the information form and give free and informed consent
• Aged 40 to 60 years
• Individual with monocular visual acuity ≥ +0.1 LogMAR with current corrections and pinhole if necessary
• Individual with a visual acuity difference ≤ 0.2 LogMAR with current corrections
• Individual with stable binocular vision in distance and near vision

You may not qualify if:

• Age \< 40 years (i.e., no minors in accordance with Article L1121-7)
• Age \> 60 years
• All categories of people specifically protected under French law are excluded from this research (Articles L1121-5 to L1121-9 of the Public Health Code):
• Pregnant, childbearing, or breastfeeding women (Article L1121-5)
• Persons deprived of their liberty by a judicial or administrative decision and persons hospitalized without consent pursuant to Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social care facility for purposes other than research
• Adults incapable or unable to express consent (Article L1121-8)
• Participants currently excluded from another study
• Participants unable to be contacted in case of emergency
• Person with strabismus
• Person with amblyopia
• Aphakic or pseudophakic person
• Person with vertical phoria \> 1 PD
• Declared neurological deficit, including a history of epileptic disorders or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders)
• Declared severe ocular pathology, involving visual field loss, such as glaucoma, or involving loss of acuity and significant discomfort in dimly or excessively lit environments, such as retinitis pigmentosa, or declared and treated dry eye.

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Essilor International - Ci&T 2

Créteil, 94000, France

Location

MeSH Terms

Conditions

Presbyopia; Myopia; Refractive Errors

Interventions

Visual Acuity

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Study Officials

• François Daniel

  ESSILOR INTERNATIONAL - Division Instruments

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 8, 2025
• Study Start: March 31, 2025
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

FR (1)