PresbyopiaCIVIUS2026PALNCT07870785
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
A study testing OPAL PC 133 assessment, OPAL PC 200 assessment and PAL assessment in people with Presbyopia, run by University of Seville at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 52 to 67 years
- Conditions the study is for
- Presbyopia
- What is being tested?
- OPAL PC 133 assessment, OPAL PC 200 assessment and PAL assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jun 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Pharmacy School, University of Seville
Seville, Andalusia, 41012
About this study
Official title: Ensayo clínico, unicéntrico, Transversal, Randomizado, Cruzado, Doble Ciego Para Evaluar Las Diferencias de Los Campos volumétricos de visión en Pacientes présbitas, Entre 400 y 40 cm., de Tres Tipos de Lentes oftálmicas Neutras de Lejos y adición Progresiva de 2 D. Dos de visión Intermedia y Cerca OPL (PC-133 y PC-200), y Otra Generalista PAL de visión Lejos, Intermedia y Cerca (FIT-FRM).
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 PC 1.5 FWD 133 cm and Vimax PC 1.5 FWD 200 cm 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.
Read more
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.
- Conditions
- Presbyopia
- Being tested
- OPAL PC 133 assessment, OPAL PC 200 assessment, PAL assessment
- Keywords
- Occupational progressive lenses, Presbyopia, Visual field depth, Visual field volume, Visual acuity
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPAL PC 133 assessmentDevice
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 PC 200 assessmentDevice
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 assessmentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| OPL designed for PC use and 133cm of visual depth field | Experimental | Occupational progressive lenses designed to provide clear vision from 133 cm to 40 cm, with a wider visual field optimized for monitor-based environments with a depth of field between 60 and 80 cm. These lenses, designated L1, were custom ordered with neutral distance power and a near addition of +2.00 D, a vertex distance of 13 mm, pantoscopic tilt of 8°, wrap angle of 6°, working distance of 40 cm, inset of 2.5 mm in both eyes, and NPD of 31 mm in each eye Receives: Device: OPAL PC 133 assessment |
| OPL designed for PC use and 200cm of visual depth field | Experimental | Occupational progressive lenses designed to provide clear vision from 200 cm to 40 cm, with a wider visual field optimized for monitor-based environments with a depth of field between 60 and 80 cm. These lenses, designated L1, were custom ordered with neutral distance power and a near addition of +2.00 D, a vertex distance of 13 mm, pantoscopic tilt of 8°, wrap angle of 6°, working distance of 40 cm, inset of 2.5 mm in both eyes, and NPD of 31 mm in each eye Receives: Device: OPAL PC 200 assessment |
| PAL | Experimental | Progressive additional lenses custom ordered with neutral distance power and a near addition of +2.00 D, vertex dis-tance of 13 mm, pantoscopic tilt of 8°, wrap angle of 6°, working distance of 40 cm, inset of 2.5 mm in both eyes, and NPD of 31 mm in both eyes. Receives: Device: PAL assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual field volume
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.
Measured: Immediately after the adjustment of the frame where the lenses were placed, an average of 30 minutes per patient.
Secondary outcomes (1)
Visual fields surface
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.
Measured: Immediately after the adjustment of the frame where the lenses were placed, an average of 30 minutes per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start8 Jun 2026
- Primary completion26 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Manuel Serrano Morales, University of Seville
- Investigators
- José Manuel Serrano Morales, PhD, Principal investigator, Pharmacy School, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870785
- Sponsor's protocol ID
- CIVIUS2026PAL
- Other IDs
- SICEIA-2026-000851
- Acronym
- CIVIUS2026PAL
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No