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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
A code was assigned to each participant and echa type of lenses. Investigators don't know which lens are being assessed during the trial.
入排标准
- 年龄范围
- 52 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究者
José Manuel Serrano Morales
Optometry degree, Pharmacy degree and PhD in Molecular Biology, Biomedicine and Clinical Research
University of Seville