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

NCT06699784 | Not Yet Recruiting DMC

• 1 other identifier: HSEARS20240916011
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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

Keywords

quality of life; presbyopia; near correction

Outcome Measures

Primary Outcomes (1)

• quality of life score

  Quality of life scores measured by a 12-item Near Vision-Related Quality of Life questionnaire.

  From enrollment to the end of intervention at 1 month

Secondary Outcomes (2)

• Other questionnaire

  From enrollment to the end of intervention at 1 month

• Visual acuity

  From enrollment to the end of intervention at 1 month

Study Arms (2)

Progressive lenses intervention group

EXPERIMENTAL

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

Behavioral: Progressive lenses intervention

Single-vision lenses intervention group

PLACEBO COMPARATOR

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.

Behavioral: Single-vision lenses intervention

Interventions

Progressive lenses intervention BEHAVIORAL

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

Progressive lenses intervention group

Single-vision lenses intervention 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.

Single-vision lenses intervention group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Mingguang He

CONTACT

85234002795; mingguang.he@polyu.edu.hk

Yanxian Chen

CONTACT

85227666111; yan-xian.chen@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share