Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses (CIVIUS2025PAL)
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.
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Sevilla
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Seville, Sevilla, Španělsko, 41012
- Pharmacy school, University of Seville
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: OPL designed for PC use
VIMAX PC: Occupational progressive lenses designed to provide clear vision from 400 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.
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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 |
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Experimentální: OPL designed for office use
VIMAX ZOOM: Occupational progressive lenses also designed to provide clear vision from 400 cm to 40 cm, but with a more homogeneous distribution of the visual field across office and home environments, with a depth of field between 40 and 400 cm.
These lenses, designated L2, were also custom ordered with neutral distance power and a near addition of +2.00 D, 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 both eyes.
|
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 |
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Aktivní komparátor: PAL
VIMAX FIT: 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.
|
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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Visual field volume
Časové okno: Immediately after the adjustment of the frame where the lenses were placed, an average of 30 minutes per patient.
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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.
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Immediately after the adjustment of the frame where the lenses were placed, an average of 30 minutes per patient.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Visual fields surface
Časové okno: Immediately after the adjustment of the frame where the lenses were placed, an average of 30 minutes per patient.
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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.
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Immediately after the adjustment of the frame where the lenses were placed, an average of 30 minutes per patient.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CIVIUS2025PAL
- SICEIA-2025-001629 (Jiný identifikátor: SICEIA: Ethics Committee for Biomedics Research of the Junta de Andalucia)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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