Comparative Study and Validation of New Methodologies for Measuring Addition

NCT ID: NCT06963138

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-05-05

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Validation of new addition measurement methodologies

Group Type: EXPERIMENTAL

Visual Acuity

Intervention Type: DEVICE

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

Objective refraction

Intervention Type: DEVICE

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

Standard Subjective refraction

Intervention Type: DEVICE

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

Near vision examination and determination of additions

Intervention Type: 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

Binocular vision tests

Intervention Type: 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

Extended trial of addition

Intervention Type: 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.

Interventions

Visual Acuity

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

Intervention Type: DEVICE

Objective refraction

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

Intervention Type: DEVICE

Standard Subjective refraction

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Essilor International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Daniel

Role: PRINCIPAL_INVESTIGATOR

ESSILOR INTERNATIONAL - Division Instruments

Locations

Essilor International - Ci&T 2

Créteil, , France

Countries

France

Other Identifiers

2023-A00122-43

Identifier Type: OTHER

Identifier Source: secondary_id

WS10331

Identifier Type: -

Identifier Source: org_study_id