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NCT Number: NCT07617090

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

52 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pharmacy school, University of Seville

Seville, Sevilla, 41012, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Visual field volume

    Time frame: Immediately after the adjustment of the frame where the lenses were placed, an average of 30 minutes per patient.

    It will consist of the volume defined by two parallel surfaces bounded by the visual fields perceived with clear horizontal and vertical vision by the patient between the distances of 4 m and 25 cm while wearing each pair of spectacles. The volume will be calculated using the Heronian formula for the volume of a quadrangular pyramidal frustum.

Secondary outcomes

  1. Visual fields surface

    Time frame: Immediately after the adjustment of the frame where the lenses were placed, an average of 30 minutes per patient.

    Calculation of the visual field surface areas defined by the patient with each lens type at distances of 4 m, 2 m, 1.33 m, 80 cm, 40 cm, and 25 cm. For this purpose, the areas corresponding to the visual field regions of the lens located between the fitting cross and the intermediate and near viewing zones were summed in a 1:2 proportion, respectively, for each measured distance.

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Ensayo clínico, unicéntrico, Transversal, Randomizado, Cruzado, Doble Ciego Para Evaluar Las Diferencias de Los Campos volumétricos de visión en Distancia Intermedia (4m) y Cerca (25cm) de Tres Tipos de Lentes oftálmicas de adición Progresiva (PAL), Dos de visión Intermedia y Cerca (PC-PAL) y Otra Generalista de Vision Lejos, Intermedia y Cerca (GPPAL), Neutros en Vision de Lejos y de 2.00 D en Vision de Cerca en Pacientes présbitas.

Acronym: CIVIUS2025PAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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