Quality of Life in Presbyopes Using Single-vision Lens and Progressive Lens Correction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Progressive lenses intervention, Single-vision lenses intervention.
- Who it may be relevant to
- Registry conditions: Presbyopia, Presbyopia Correction. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Quality of Life in Presbyopes Using Single-vision Lens and Progressive Lens Correction: a Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral Progressive lenses intervention
Progressive lenses intervention group will receive 1-month progressive lens correction in daily life. - Behavioral 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.
Primary outcome measures
- quality of life score [Time frame: From enrollment to the end of intervention at 1 month]
Secondary outcome measures (2)
- Other questionnaire [Time frame: From enrollment to the end of intervention at 1 month]
- Visual acuity [Time frame: From enrollment to the end of intervention at 1 month]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06699784 · HSEARS20240916011