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RECRUITING Not applicable ClinicalTrials.gov

Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses

Sponsor: University of Seville • ClinicalTrials.gov ID: NCT07617090

Registry updated: 2026-10-15
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Description

This single-center, randomized, double-blind, crossover clinical trial aims to compare the volumetric visual fields provided by two occupational progressive addition lenses (OPLs) optimized for intermediate and near vision in presbyopic patients. The study evaluates Vimax Zoom 1.5 FWD 4 m and Vimax PC 1.5 FWD 4 m lenses and Vimax Fit FRM, all of them with plano distance power and a +2.00 D near addition, in order to determine differences in the extent of clear vision at multiple working distances. Participants will undergo a comprehensive optometric examination including medical and ocular history, visual acuity assessment, accommodative amplitude measurement, autorefraction, interpupillary distance measurement, ocular motility evaluation, confrontation visual fields, Amsler grid testing, and binocular vision assessment. Visual field measurements will then be performed using both study lenses under standardized conditions. Subjects will be instructed to maintain a fixed head position while identifying optotypes located at distances of 4 m, 2 m, 1.33 m, 80 cm, 40 cm, and 25 cm. Both lenses will be tested in random order under masked conditions so that neither participants nor investigators know which lens design is being evaluated during each phase. At least 23 presbyopic participants are expected to be enrolled. The study procedures are non-invasive and are anticipated to be completed in a single one-hour visit, although additional sessions may be scheduled if necessary. No significant risks are expected beyond possible transient visual fatigue associated with the duration of testing. The primary objective is to determine which occupational progressive lens design provides a greater spatial volume of clear vision and wider horizontal and vertical visual fields at different intermediate and near distances. The findings may contribute to improving personalized recommendations of occupational lenses according to patients' visual demands and working distances.

Interventions

  • OPAL PC assesment (Device)
    Fitting and positioning of the spectacles : participants were instructed to move only their eyes and to verbally identify the letters indicated by the optometrist. Measurement of clear vision limits: the horizontal and vertical boundaries of clear vision were recorded on a scaled results sheet, as defined by the participant using the optotype, at distances of 400, 200, 133, 80, 40, and 25 cm, in that order
  • OPAL Office assessment (Device)
    Fitting and positioning of the spectacles : participants were instructed to move only their eyes and to verbally identify the letters indicated by the optometrist. Measurement of clear vision limits: the horizontal and vertical boundaries of clear vision were recorded on a scaled results sheet, as defined by the participant using the optotype, at distances of 400, 200, 133, 80, 40, and 25 cm, in that order
  • PAL assesment (Device)
    Fitting and positioning of the spectacles : participants were instructed to move only their eyes and to verbally identify the letters indicated by the optometrist. Measurement of clear vision limits: the horizontal and vertical boundaries of clear vision were recorded on a scaled results sheet, as defined by the participant using the optotype, at distances of 400, 200, 133, 80, 40, and 25 cm, in that order

Eligibility criteria

Inclusion Criteria: * Spherical ametropia for distance vision ≤ ±4.00 D and astigmatic ametropia ≤ 1.00 D. * Decimal VA ≥ 0.8, either uncorrected (UCVA) or corrected (BCVA) with monofocal contact lenses. * Patients with a nasopupillary distance (NPD) of 31 mm, with a tolerance of ±2 mm in each eye Exclusion Criteria: * Astigmatism greater than ±1.00 D. * Patients wearing progressive contact lenses. * Patients who have undergone cataract surgery or have monofocal or multifocal intraocular lenses. * Anisometropia greater than 2.50 D. * Decimal distance visual acuity \< 0.8 (UCVA or BCVA) with monofocal contact lenses. * Patients without normal ocular motility or with partial dysfunction of one or more ex-traocular muscles, or with restricted visual fields or scotomas. * Visual suppression in one eye between 4 m and 25 cm. * Strabismus or nystagmus.

Conditions

Presbyopia

Locations

  • Phaculty of Pharmacy, University of Seville — Seville, Andalusia, Spain
  • Pharmacy school, University of Seville — Seville, Sevilla, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record