Quality of Life in Presbyopes Using Single-vision Lens and Progressive Lens Correction

Официальное название

Quality of Life in Presbyopes Using Single-vision Lens and Progressive Lens Correction: a Randomized Controlled Trial

Обзор

The goal of this clinical trial is to compare the quality of life (QOL) of presbyopes wearing progressive addition lenses (PALs) with that of those wearing single-vision spectacles (SVSs) for near correction. The main questions it aims to answer is: What is the difference in QOL between presbyopes who use SVSs and those who use PALs ? Eligible participants will be randomly assigned in a 1:1 ratio to either the PALs group or the SVSs group.Participants in the progressive lenses intervention group will receive 1-month progressive lens correction in daily life. And participants in single-vision lenses intervention group will use near-vision spectacles during near work and use their original habitual distant glasses for distance tasks for 1 month. The study will compare the QOL scores measured by a 12-item Near Vision-Related Quality of Life questionnaire between the two groups. Additionally, the study will compare the scores measured by the Refractive Status and Vision Profile questionnaire and Visual Analogue Scale questionnaire between the two groups as well as assess the change in the above three questionnaires scores at 1 month following enrollment. And visual acuity of subjects will also be assessed at baseline and at the 1-month follow-up.

Вмешательства

• Поведенческое Progressive lenses intervention
  Progressive lenses intervention group will receive 1-month progressive lens correction in daily life.
• Поведенческое Single-vision lenses intervention
  Single-vision lenses intervention group will use near-vision spectacles during near work and use their original habitual distant glasses for distance tasks for 1 month.

Первичные конечные точки

• quality of life score [Срок оценки: From enrollment to the end of intervention at 1 month]

Вторичные конечные точки (2)

• Other questionnaire [Срок оценки: From enrollment to the end of intervention at 1 month]
• Visual acuity [Срок оценки: From enrollment to the end of intervention at 1 month]

Критерии участия

Критерии включения

• Age 40-70 years;
• A distant correction of ≤2D for hyperopia, or >-2 D for myopia, or < 2D for astigmatism in both eyes;
• Anisometropia of less than 1.50 D;
• Distance best-corrected visual acuity (BCVA) of at least 0.5 LogMAR, and near VA < N8 (20/50) at 40 cm with habitually worn distance refractive correction, with improvement of near vision by at least one line on a near LogMAR E chart with the use of a plus lens;
• Have not undergone any near correction in the past six months;
• Able to answer a questionnaire;
• Giving written consent to participate in the study.

Критерии исключения

• Ocular abnormalities leading to visual impairment including severe cataract, glaucoma, strabismus, and ocular fundus diseases;
• Severe physiological and psychological diseases affecting follow-up;
• History of cataract surgery, phakic intraocular lens surgery, corneal surgery, or any intraocular surgery affecting the refractive status of the eye;
• Have used pilocarpine in the past six months.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06699784 · HSEARS20240916011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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