Clinical trial NCT06699784: Quality of Life in Presbyopes Using Single-vision Lens and Progressive Lens Correction
Official title: Quality of Life in Presbyopes Using Single-vision Lens and Progressive Lens Correction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Presbyopia
Presbyopia Correction
Keywords: quality of life
presbyopia
near correction
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

1. Age 40-70 years;
2. A distant correction of ≤2D for hyperopia, or \>-2 D for myopia, or \< 2D for astigmatism in both eyes;
3. Anisometropia of less than 1.50 D;
4. 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;
5. Have not undergone any near correction in the past six months;
6. Able to answer a questionnaire;
7. Giving written consent to participate in the study.

Exclusion Criteria:

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

Primary outcomes:
measure: quality of life score
timeFrame: From enrollment to the end of intervention at 1 month
Secondary outcomes:
measure: Other questionnaire
timeFrame: From enrollment to the end of intervention at 1 month
measure: Visual acuity
timeFrame: From enrollment to the end of intervention at 1 month
Other outcomes:
Locations:
Study officials:
References: