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| Name | Class |
|---|---|
| Hoya Vision Care | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: The specified PAL design wearers | Experimental | Subjects who have been already wearing any from specified design type of PAL |
|
| The other PAL design wearers | Active Comparator | Subjects who have been already wearing any from the other design type of PAL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating | Device | Subjects will be wearing three different PAL designs with different geometries of the optical progression. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Entire study duration (approx. 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Directly after receiving the lenses (approx. 15 minutes) |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Spors, Ph.D. | Western University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western University of Health Sciences | Pomona | California | 91766 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | For each participant, three pairs of progressive addition lenses were analyzed. Each pair was worn for one week. | Posted | Mean | Standard Deviation | score on a scale | Entire study duration (approx. 4 weeks) | Progressive Addition Lenses | Progressive Addition Lenses |
|
Through study completion, 6 months
Each participant wore three pairs of progressive addition lenses for a total of three weeks. Potential adverse events included: Product Issues and Eye Disorders (reduced vision). The principal investigator was available for the study participants at any time during the study by phone and email to report adverse events. During the scheduled follow-up visits, participants were specifically asked for potential adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: The Specified PAL Design Wearers, Wearing Pair 1 | Subjects who have already been wearing the specified design type of PAL and wearing Pair 1 of the study lenses. 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. |
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There are no limitations to be reported. The study went as planned.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank Spors | Western University of Health Sciences | 9097063883 | fspors@westernu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2021 | Dec 29, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2021 | Dec 29, 2023 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Progressive addition lens designs are unknown to participants, investigators, and outcomes assessors.
| 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" | Entire study duration (approx. 4 weeks) |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | The Other PAL Design Wearers, Wearing Pair 1 | Subjects who have been wearing any other design type of PAL and wearing Pair 1 of the study lenses. 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. |
| OG002 | Experimental: The Specified PAL Design Wearers, Wearing Pair 2 | Subjects who have already been wearing the specified design type of PAL and wearing Pair 2 of the study lenses. 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. |
| OG003 | The Other PAL Design Wearers, Wearing Pair 2 | Subjects who have been wearing any other design type of PAL and wearing Pair 2 of the study lenses. 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. |
| OG004 | Experimental: The Specified PAL Design Wearers, Wearing Pair 3 | Subjects who have already been wearing the specified design type of PAL and wearing Pair 3 of the study lenses. 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. |
| OG005 | The Other PAL Design Wearers, Wearing Pair 3 | Subjects who have been wearing any other design type of PAL and wearing Pair 3 of the study lenses. 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Directly after receiving the lenses (approx. 15 minutes) | Progressive Addition Lenses | Progressive Addition Lenses |
|
|
|
| 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" | For each participant, three pairs of progressive addition lenses were analyzed. Each pair was worn for one week. | Posted | Number | participants | Entire study duration (approx. 4 weeks) | Progressive Addition Lenses | Progressive Addition Lenses |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | The Other PAL Design Wearers, Wearing Pair 1 | Subjects who have been wearing any other design type of PAL and wearing Pair 1 of the study lenses. 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. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | Experimental: The Specified PAL Design Wearers, Wearing Pair 2 | Subjects who have already been wearing the specified design type of PAL and wearing Pair 2 of the study lenses. 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. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG003 | The Other PAL Design Wearers, Wearing Pair 2 | Subjects who have been wearing any other design type of PAL and wearing Pair 2 of the study lenses. 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. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG004 | Experimental: The Specified PAL Design Wearers, Wearing Pair 3 | Subjects who have already been wearing the specified design type of PAL and wearing Pair 3 of the study lenses. 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. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG005 | The Other PAL Design Wearers, Wearing Pair 3 | Subjects who have been wearing any other design type of PAL and wearing Pair 3 of the study lenses. 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. | 0 | 40 | 0 | 40 | 0 | 40 |
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| Progressive Addition Lenses |
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| Progressive Addition Lenses |
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