Presbyopia
Conditions
Brief summary
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.
Detailed description
The purpose of the study is to evaluate the preference, adaptability, and visual performance of three progressive lens designs. The difference in these lens designs is a variation of zone sizes for intermediate and near vision. The clinical trial helps manufacturers and eye care practitioners to give detailed suggestions to patients. Study participants will be experienced progressive addition lens wearers, which will be recruited by advertisements, by email, and with direct person-to-person solicitation. The study will be conducted at the Eye Care Institute at the Patient Care Center Western University of Health Sciences, Pomona, CA, 91766. For each participant, the study is completed in around two months and requires three separate visits.
Interventions
Subjects will be wearing three different PAL designs with different geometries of the optical progression.
Sponsors
Hoya Vision Care
Western University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Progressive addition lens designs are unknown to participants, investigators, and outcomes assessors.
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 45 to 70 years old. * Visual Acuity: far & near monocular: cc ≥ 20/20 (decimal cc ≥ 1.0) * Normal binocular vision (at distance & near: no strabismus on cover testing, aligning prism of less than 2Δ horizontally or vertically, stereoacuity of 2' or better at distance and near). * Prescription is in the range: * Spherical power: less than +/-6.00 D * Cylindrical power: less than -2.75 D * Addition: 1.50 D - 2.50 D * Difference in power (spherical equivalent) between eyes: less than 2.00 D
Exclusion criteria
* Have never worn any progressive lens design. * First prescription for progressive lenses. * Prescription found during visit#1 varies from current prescription more than 0.50 D in any meridian. * Currently wearing single vision lenses with accommodative support. * Double vision or prismatic prescription in current glasses. * Known ocular disease including strabismus, any pathology, any eye surgeries that may affect visual acuity. * Use of systemic or ocular medications that are likely to affect vision. * Balance problem/vertigo problem. * Concurrent participation in other vision-related research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Adaptation to Progressive Lens Designs. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Immediate Preference Among Progressive Lens Designs. | 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. |
| Evaluate the Preference of Progressive Lens Designs. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental: The Specified PAL Design Wearers Subjects who have been already wearing any from specified design type of PAL
Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating: Subjects will be wearing three different PAL designs with different geometries of the optical progression. | 40 |
| The Other PAL Design Wearers Subjects who have been already wearing any from the other design type of PAL
Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating: Subjects will be wearing three different PAL designs with different geometries of the optical progression. | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | The Other PAL Design Wearers | Total | Experimental: The Specified PAL Design Wearers |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 8 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 72 Participants | 35 Participants |
| Age, Continuous | 55.6 years STANDARD_DEVIATION 6.42 | 55.5 years STANDARD_DEVIATION 6.73 | 55.3 years STANDARD_DEVIATION 7.11 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Female | 21 Participants | 46 Participants | 25 Participants |
| Sex: Female, Male Male | 19 Participants | 34 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
Evaluate the Adaptation to Progressive Lens Designs.
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.
Time frame: Entire study duration (approx. 4 weeks)
Population: For each participant, three pairs of progressive addition lenses were analyzed. Each pair was worn for one week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: The Specified PAL Design Wearers, Wearing Pair 1 | Evaluate the Adaptation to Progressive Lens Designs. | 4.125 score on a scale | Standard Deviation 0.822 |
| The Other PAL Design Wearers, Wearing Pair 1 | Evaluate the Adaptation to Progressive Lens Designs. | 4.025 score on a scale | Standard Deviation 1.05 |
| Experimental: The Specified PAL Design Wearers, Wearing Pair 2 | Evaluate the Adaptation to Progressive Lens Designs. | 3.875 score on a scale | Standard Deviation 0.992 |
| The Other PAL Design Wearers, Wearing Pair 2 | Evaluate the Adaptation to Progressive Lens Designs. | 3.725 score on a scale | Standard Deviation 0.987 |
| Experimental: The Specified PAL Design Wearers, Wearing Pair 3 | Evaluate the Adaptation to Progressive Lens Designs. | 4.300 score on a scale | Standard Deviation 0.939 |
| The Other PAL Design Wearers, Wearing Pair 3 | Evaluate the Adaptation to Progressive Lens Designs. | 4.150 score on a scale | Standard Deviation 0.864 |
Secondary
Evaluate the Immediate Preference Among Progressive Lens Designs.
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.
Time frame: Directly after receiving the lenses (approx. 15 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental: The Specified PAL Design Wearers, Wearing Pair 1 | Evaluate the Immediate Preference Among Progressive Lens Designs. | 4.550 score on a scale | Standard Deviation 0.714 |
| The Other PAL Design Wearers, Wearing Pair 1 | Evaluate the Immediate Preference Among Progressive Lens Designs. | 4.400 score on a scale | Standard Deviation 0.709 |
| Experimental: The Specified PAL Design Wearers, Wearing Pair 2 | Evaluate the Immediate Preference Among Progressive Lens Designs. | 4.625 score on a scale | Standard Deviation 0.667 |
| The Other PAL Design Wearers, Wearing Pair 2 | Evaluate the Immediate Preference Among Progressive Lens Designs. | 4.450 score on a scale | Standard Deviation 0.783 |
| Experimental: The Specified PAL Design Wearers, Wearing Pair 3 | Evaluate the Immediate Preference Among Progressive Lens Designs. | 4.625 score on a scale | Standard Deviation 0.568 |
| The Other PAL Design Wearers, Wearing Pair 3 | Evaluate the Immediate Preference Among Progressive Lens Designs. | 4.400 score on a scale | Standard Deviation 0.672 |
Secondary
Evaluate the Preference of Progressive Lens Designs.
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
Time frame: Entire study duration (approx. 4 weeks)
Population: For each participant, three pairs of progressive addition lenses were analyzed. Each pair was worn for one week.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: The Specified PAL Design Wearers, Wearing Pair 1 | Evaluate the Preference of Progressive Lens Designs. | 11 participants |
| The Other PAL Design Wearers, Wearing Pair 1 | Evaluate the Preference of Progressive Lens Designs. | 16 participants |
| Experimental: The Specified PAL Design Wearers, Wearing Pair 2 | Evaluate the Preference of Progressive Lens Designs. | 10 participants |
| The Other PAL Design Wearers, Wearing Pair 2 | Evaluate the Preference of Progressive Lens Designs. | 9 participants |
| Experimental: The Specified PAL Design Wearers, Wearing Pair 3 | Evaluate the Preference of Progressive Lens Designs. | 19 participants |
| The Other PAL Design Wearers, Wearing Pair 3 | Evaluate the Preference of Progressive Lens Designs. | 15 participants |