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

Quality of Life in Presbyopes Using Single-vision Lens and Progressive Lens Correction: a Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Presbyopia; Presbyopia Correction
• Intervention / Treatment: Behavioral: Progressive lenses intervention; Behavioral: Single-vision lenses intervention

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingguang He; Phone Number: 85234002795; Email: mingguang.he@polyu.edu.hk
• Study Contact Backup: Name: Yanxian Chen; Phone Number: 85227666111; Email: yan-xian.chen@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progressive lenses intervention group; Progressive lenses intervention group will receive 1-month progressive lens correction in daily life.	Behavioral: Progressive lenses intervention; Progressive lenses intervention group will receive 1-month progressive lens correction in daily life.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other questionnaire	•The scores of the refractive status and vision profile (RSVP) questionnaire and visual analogue scale (VAS).	From enrollment to the end of intervention at 1 month
Visual acuity	Near and distance best-corrected visual acuity.	From enrollment to the end of intervention at 1 month

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Estimated): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; presbyopia; near correction
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: HSEARS20240916011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No