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Not yet recruitingNCT06699784Updated Nov 21, 2024

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

An interventional study of Progressive lenses intervention and Single-vision lenses intervention in Presbyopia and Presbyopia Correction, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Presbyopia
  • Presbyopia Correction

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Keywords

  • quality of life
  • presbyopia
  • near correction
03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's planned enrollment of 74 is above the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    Progressive lenses intervention group

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

    Behavioral: Progressive lenses intervention

  • 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

Interventions

  • BehavioralProgressive lenses intervention

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

  • BehavioralSingle-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.

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What researchers measure

Primary outcomes

  1. quality of life score

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

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

Secondary outcomes

  1. Other questionnaire

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

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

  2. Visual acuity

    Near and distance best-corrected visual acuity.

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06699784
Responsible party
Sponsor
First posted
Nov 21, 2024
Start date
Dec 2024 (estimated)
Primary completion
Jun 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Nov 21, 2024

Study contacts

Mingguang He
Contact
mingguang.he@polyu.edu.hk
85234002795
Yanxian Chen
Contact
yan-xian.chen@polyu.edu.hk
85227666111

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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