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

NCT ID: NCT06699784

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2025-12-31

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.

Conditions

Presbyopia; Presbyopia Correction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Progressive lenses intervention group

Progressive lenses intervention group will receive 1-month progressive lens correction in daily life.

Group Type: EXPERIMENTAL

Progressive lenses intervention

Intervention Type: BEHAVIORAL

Progressive lenses intervention group will receive 1-month progressive lens correction in daily life.

Single-vision lenses intervention group

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.

Group Type: PLACEBO_COMPARATOR

Single-vision lenses intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Progressive lenses intervention

Progressive lenses intervention group will receive 1-month progressive lens correction in daily life.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Mingguang He

Role: CONTACT

mingguang.he@polyu.edu.hk

85234002795

Yanxian Chen

Role: CONTACT

yan-xian.chen@polyu.edu.hk

85227666111

Other Identifiers

HSEARS20240916011

Identifier Type: -

Identifier Source: org_study_id