Trial Outcomes & Findings for Assessment of Three Basic Progressive Lens Designs (NCT NCT05252871)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

80 participants

Primary outcome timeframe

Entire study duration (approx. 4 weeks)

Results posted on

2024-08-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: The Specified PAL Design Wearers n=40 Participants 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.	The Other PAL Design Wearers n=40 Participants 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.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=40 Participants	0 Participants n=40 Participants	0 Participants n=80 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=40 Participants	37 Participants n=40 Participants	72 Participants n=80 Participants
Age, Categorical >=65 years	5 Participants n=40 Participants	3 Participants n=40 Participants	8 Participants n=80 Participants
Age, Continuous	55.3 years STANDARD_DEVIATION 7.11 • n=40 Participants	55.6 years STANDARD_DEVIATION 6.42 • n=40 Participants	55.5 years STANDARD_DEVIATION 6.73 • n=80 Participants
Sex: Female, Male Female	25 Participants n=40 Participants	21 Participants n=40 Participants	46 Participants n=80 Participants
Sex: Female, Male Male	15 Participants n=40 Participants	19 Participants n=40 Participants	34 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	40 Participants n=40 Participants	40 Participants n=40 Participants	80 Participants n=80 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Experimental: The Specified PAL Design Wearers, Wearing Pair 1 n=80 Progressive Addition Lenses 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.	The Other PAL Design Wearers, Wearing Pair 1 n=80 Progressive Addition Lenses 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.	Experimental: The Specified PAL Design Wearers, Wearing Pair 2 n=80 Progressive Addition Lenses 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.	The Other PAL Design Wearers, Wearing Pair 2 n=80 Progressive Addition Lenses 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.	Experimental: The Specified PAL Design Wearers, Wearing Pair 3 n=80 Progressive Addition Lenses 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.	The Other PAL Design Wearers, Wearing Pair 3 n=80 Progressive Addition Lenses 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.
Evaluate the Adaptation to Progressive Lens Designs.	4.125 score on a scale Standard Deviation 0.822	4.025 score on a scale Standard Deviation 1.05	3.875 score on a scale Standard Deviation 0.992	3.725 score on a scale Standard Deviation 0.987	4.300 score on a scale Standard Deviation 0.939	4.150 score on a scale Standard Deviation 0.864

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental: The Specified PAL Design Wearers, Wearing Pair 1 n=40 Participants 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.	The Other PAL Design Wearers, Wearing Pair 1 n=80 Progressive Addition Lenses 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.	Experimental: The Specified PAL Design Wearers, Wearing Pair 2 n=80 Progressive Addition Lenses 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.	The Other PAL Design Wearers, Wearing Pair 2 n=80 Progressive Addition Lenses 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.	Experimental: The Specified PAL Design Wearers, Wearing Pair 3 n=80 Progressive Addition Lenses 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.	The Other PAL Design Wearers, Wearing Pair 3 n=80 Progressive Addition Lenses 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.
Evaluate the Immediate Preference Among Progressive Lens Designs.	4.550 score on a scale Standard Deviation 0.714	4.400 score on a scale Standard Deviation 0.709	4.625 score on a scale Standard Deviation 0.667	4.450 score on a scale Standard Deviation 0.783	4.625 score on a scale Standard Deviation 0.568	4.400 score on a scale Standard Deviation 0.672

SECONDARY outcome

Timeframe: 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.

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"