Quality of Life in Presbyopes Using Single-vision Lens and Progressive Lens Correction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Progressive lenses intervention
BehavioralProgressive lenses intervention group will receive 1-month progressive lens correction in daily life.
Single-vision lenses intervention
BehavioralSingle-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.
Treatment groups
74 Participants
are divided into 2 treatment groupsGroup A: Progressive lenses intervention groupExperimental treatment 1 intervention
Group B: Single-vision lenses intervention groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
quality of life score
Quality of life scores measured by a 12-item Near Vision-Related Quality of Life questionnaire.
Time frame
From enrollment to the end of intervention at 1 monthSecondary outcomes
1
Other questionnaire
•The scores of the refractive status and vision profile (RSVP) questionnaire and visual analogue scale (VAS).
Time frame
From enrollment to the end of intervention at 1 month2
Visual acuity
Near and distance best-corrected visual acuity.
Time frame
From enrollment to the end of intervention at 1 monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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