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NCT Number: NCT06699784

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Presbyopia Correction Refractive Errors

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Progressive lenses intervention

Behavioral

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

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.

Primary outcomes

  1. quality of life score

    Time frame: From enrollment to the end of intervention at 1 month

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

Secondary outcomes

  1. Other questionnaire

    Time frame: From enrollment to the end of intervention at 1 month

    •The scores of the refractive status and vision profile (RSVP) questionnaire and visual analogue scale (VAS).

  2. Visual acuity

    Time frame: From enrollment to the end of intervention at 1 month

    Near and distance best-corrected visual acuity.

Study contacts

Contact information is provided by the study sponsor or research team.

Mingguang He

CONTACT

[email protected]

85234002795

Yanxian Chen

CONTACT

[email protected]

85227666111

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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