Comparing methods for measuring near vision correction in presbyopic patients
Comparative Study and Validation of New Methodologies for Measuring Addition
This study is testing different ways to measure near vision correction for people with presbyopia to find the best method for getting them the right glasses or lenses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | All |
| Sponsor | Essilor International Industry-sponsored |
| Locations | 1 site (Créteil) |
| Trial ID | NCT06963138 on ClinicalTrials.gov |
What this trial studies
This research aims to gather extensive data on individuals with presbyopia to identify the most effective tests for determining the optimal addition for near vision correction. The study will evaluate both subjective and objective measurement techniques, including visual acuity assessments and various refraction methods. By comparing these methodologies, the goal is to enhance the accuracy of near vision prescriptions, ensuring they meet the daily visual needs of patients. Participants will undergo a series of tests to assess their refractive status and determine the best addition value for their vision.
Who should consider this trial
Good fit: Ideal candidates are French-speaking individuals aged 40 to 60 with stable binocular vision and specific visual acuity criteria.
Not a fit: Patients under 40 or over 60 years old, as well as those with certain legal or health restrictions, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate prescriptions for near vision correction, improving the quality of life for presbyopic patients.
How similar studies have performed: While there have been studies on refraction methods, this specific comparative approach to measuring additions in presbyopia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Créteil
- Essilor International - Ci&T 2 — Créteil, France (Recruiting)
Study contacts
- Principal investigator: François Daniel — ESSILOR INTERNATIONAL - Division Instruments
- Study coordinator: Paul-Henri Prévot
- Email: prevotph@essilor.fr
- Phone: +33 (0) 1 72 94 70 09
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.