Assessment of Three Basic Progressive Lens Designs
CompletedNAResults postedLast updated 15 August 2024
What this trial tests
NA trial testing Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating in Presbyopia in 80 participants. Completed in 6 June 2022.
Timeline
9 December 2021
Primary endpoint 6 June 2022
6 June 2022
Quick facts
Lead sponsor
Western University of Health Sciences
Phase
NA
Status
Completed
Study type
INTERVENTIONAL
Allocation
randomized
Design
parallel
Masking
triple
Primary purpose
treatment
Enrollment
80
Start date
9 December 2021
Primary completion
6 June 2022
Estimated completion
6 June 2022
Sites
1 location across United States
Drugs / interventions tested
Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating
Adults 45 to 70, any sex, with Presbyopia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Evaluate the Adaptation to Progressive Lens Designs.Primary· Entire study duration (approx. 4 weeks)
Evaluate the adaptation to progressive lens designs through a "Satisfaction questionnaire" after 1 week of use of each of the 3 progressive addition lenses.
Scale titles: Visual Quality Scale: A 5-point scale from a minimum value of 1 to a maximum score of 5. Higher scores mean better outcomes.
Group
Value
95% CI
Experimental: The Specified PAL Design Wearers, Wearing Pair 1
4.125
± 0.822
The Other PAL Design Wearers, Wearing Pair 1
4.025
± 1.05
Experimental: The Specified PAL Design Wearers, Wearing Pair 2
3.875
± 0.992
The Other PAL Design Wearers, Wearing Pair 2
3.725
± 0.987
Experimental: The Specified PAL Design Wearers, Wearing Pair 3
4.300
± 0.939
The Other PAL Design Wearers, Wearing Pair 3
4.150
± 0.864
Evaluate the Immediate Preference Among Progressive Lens Designs.Secondary· Directly after receiving the lenses (approx. 15 minutes)
Evaluate the immediate preference for progressive lens designs through a "Satisfaction questionnaire" directly after receiving the 3 progressive addition lenses.
Scale titles: Visual Quality Scale: A 5-point scale from a minimum value of 1 to a maximum score of 5. Higher scores mean better outcomes.
Group
Value
95% CI
Experimental: The Specified PAL Design Wearers, Wearing Pair 1
4.550
± 0.714
The Other PAL Design Wearers, Wearing Pair 1
4.400
± 0.709
Experimental: The Specified PAL Design Wearers, Wearing Pair 2
4.625
± 0.667
The Other PAL Design Wearers, Wearing Pair 2
4.450
± 0.783
Experimental: The Specified PAL Design Wearers, Wearing Pair 3
4.625
± 0.568
The Other PAL Design Wearers, Wearing Pair 3
4.400
± 0.672
Evaluate the Preference of Progressive Lens Designs.Secondary· Entire study duration (approx. 4 weeks)
Evaluate the final preference of progressive lens designs after wearing each of the 3 PALs for one week.
Scale title: Preference of Progressive Addition Lenses Scale: "Pair 1", "Pair 2, "Pair 3"
Group
Value
95% CI
Experimental: The Specified PAL Design Wearers, Wearing Pair 1
11
The Other PAL Design Wearers, Wearing Pair 1
16
Experimental: The Specified PAL Design Wearers, Wearing Pair 2
10
The Other PAL Design Wearers, Wearing Pair 2
9
Experimental: The Specified PAL Design Wearers, Wearing Pair 3
19
The Other PAL Design Wearers, Wearing Pair 3
15
Sponsor's own description
This clinical trial investigates the differences between three different progressive addition lens designs. It is a non-invasive double-masked randomized clinical investigation. For this study, 80 participants will be recruited.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Western University of Health Sciences
Last refreshed: 15 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05252871.