Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm

Prospective Clinical Study to Evaluate the Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm

This is a prospective, comparative, randomized, controlled, open-label, single-surgeon, single-center PMCF clinical study whereby presbyopic patients undergoing refractive surgery will receive a SUPRACOR treatment for the correction in the non-dominant eye and a PROSCAN refractive treatment in the dominant eye to correct for ametropia.

The participants will be randomized to either a SUPRACOR regular (100%) or SUPRACOR strong (130%) treatment with a 1:1 ratio.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Procedure: SUPRACOR Regular; Procedure: SUPRACOR Strong

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Makati City, Philippines
    • Asian Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• presbyopia
• willingness for a refractive presbyopia correction
• signed informed consent form

Exclusion Criteria:

- ocular comorbidity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SUPRACOR Regular	Procedure: SUPRACOR Regular; SUPRACOR algorithm with regular (100%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction.
Experimental: SUPRACOR Strong	Procedure: SUPRACOR Strong; SUPRACOR algorithm with strong (130%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Uncorrected Distance Visual Acuity (UDVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.	3 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monocular Uncorrected Distance Visual Acuity (UDVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.	3 months follow up
Monocular Corrected Distance Visual Acuity (CDVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions. Corrected means spectacle corrected.	3 months follow up
Binocular Corrected Distance Visual Acuity (CDVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions. Corrected means spectacle corrected.	3 months follow up
Monocular Uncorrected Intermediate Visual Acuity (UIVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 80 cm (intermediate distance) in LogMAR scale under photopic light conditions.	3 months follow up
Binocular Uncorrected Intermediate Visual Acuity (UIVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 80 cm (intermediate distance) in LogMAR scale under photopic light conditions.	3 months follow up
Monocular Uncorrected Near Visual Acuity (UNVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 40 cm (near distance) in LogMAR scale under photopic light conditions.	3 months follow up
Binocular Uncorrected Near Visual Acuity (UNVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 40 cm (near distance) in LogMAR scale under photopic light conditions.	3 months follow up
Binocular Defocus Curve	To assess the visual acuity for different distances, defocus curves under photopic light conditions will be measured using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) device at 4m. This test is performed with best distance corrected refraction and spherical additions ranging from -4.5 D to +1.0 D in 0.5D steps.	3 months follow up
Binocular Contrast sensitivity	The contrast sensitivity test consists in assessing the possibility to distinguish the alternation of white and grey fringes of difference contrast with difference frequency. Contrast sensitivity will be assessed under photopic and mesopic light conditions using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) device at 2.5 m.	3 months follow up
Halo Photic phenomena	The amount and disturbance of photic halo side effects will be assessed by two methods: 1) Halo and Glare simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of glare and halo; 2) Siepser Glarometer (Gulden Ophthalmics, Elkins Park, PA 19027). This is a target-like device that measures and quantifies post-operative glare. The measurement is of the participants' actual scope and range of monocular glare and halo.	3 months follow up
Glare Photic phenomena	The amount and disturbance of photic glare side effects will be assessed by two methods: 1) Halo and Glare simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of glare and halo; 2) Siepser Glarometer (Gulden Ophthalmics, Elkins Park, PA 19027). This is a target-like device that measures and quantifies post-operative glare. The measurement is of the participants' actual scope and range of monocular glare and halo.	3 months follow up
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)	The Patient-Reported Spectacle Independence Questionnaire (PRSIQ) is comprised of 3 questions about the need for glasses or contacts in the past 7 days for distance vision (at least 1.5 meters (m) away), intermediate vision (0.5 m to 1.5 m away), and near vision (< 0.5 m away). Possible scores range from 1 to 5, with 1 = All of the time and 5 = None of the time for six of the questions; 3 of these questions ask the question in a positive way and 3 of the question ask the question in a negative way, so the higher scores are better for the negative question and are worse for the positive question. There are also 3 questions whether glasses or contacts were needed in the past 7 days with scores of Yes = 1 and No = 2. The results for each question will be summarized separately.	3 months follow up
Near Activity Visual Questionnaire (NAVQ)	The Near Activity Visual Questionnaire (NAVQ) is comprised of 10 questions about performing activities without extra reading spectacles. Each question has responses of 0 to 4, with 0 indicating 'No difficulty' and 4 indicating 'Extreme difficulty'. Any 'Not applicable' responses are scored according to the median overall score for the subject. The scores are summed with total score ranging from 0 to 30. Higher scores indicate more difficulty performing specified activities without spectacles.	3 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Uncorrected Distance Visual Acuity (UDVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.	12 months follow up
Monocular Uncorrected Distance Visual Acuity (UDVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.	12 months follow up
Monocular Corrected Distance Visual Acuity (CDVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m, 80 cm and 40 cm in LogMAR scale under photopic light conditions. Corrected means spectacle corrected.	12 months follow up
Binocular Corrected Distance Visual Acuity (CDVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 4 m, 80 cm and 40 cm in LogMAR scale under photopic light conditions. Corrected means spectacle corrected.	12 months follow up
Monocular Uncorrected Intermediate Visual Acuity (UIVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 80 cm (intermediate distance) in LogMAR scale under photopic light conditions.	12 months follow up
Binocular Uncorrected Intermediate Visual Acuity (UIVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 80 cm (intermediate distance) in LogMAR scale under photopic light conditions.	12 months follow up
Monocular Uncorrected Near Visual Acuity (UNVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 40 cm (near distance) in LogMAR scale under photopic light conditions.	12 months follow up
Binocular Uncorrected Near Visual Acuity (UNVA)	The visual acuity measurements will be assessed using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) at 40 cm (near distance) in LogMAR scale under photopic light conditions.	12 months follow up
Binocular Defocus Curve	To assess the visual acuity for different distances, defocus curves under photopic light conditions will be measured using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) device at 4m. This test is performed with best distance corrected refraction and spherical additions ranging from -4.5 D to +1.0 D in 0.5D steps.	12 months follow up
Binocular Contrast sensitivity	The contrast sensitivity test consists in assessing the possibility to distinguish the alternation of white and grey fringes of difference contrast with difference frequency. Contrast sensitivity will be assessed under photopic and mesopic light conditions using Clinical Trial Suite (M&S Technologies, Niles, IL, USA) device at 2.5 m.	12 months follow up
Halo Photic phenomena	The amount and disturbance of photic halo side effects will be assessed by two methods: 1) Halo and Glare simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of glare and halo; 2) Siepser Glarometer (Gulden Ophthalmics, Elkins Park, PA 19027). This is a target-like device that measures and quantifies post-operative glare. The measurement is of the participants' actual scope and range of monocular glare and halo.	12 months follow up
Glare Photic phenomena	The amount and disturbance of photic glare side effects will be assessed by two methods: 1) Halo and Glare simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of glare and halo; 2) Siepser Glarometer (Gulden Ophthalmics, Elkins Park, PA 19027). This is a target-like device that measures and quantifies post-operative glare. The measurement is of the participants' actual scope and range of monocular glare and halo.	12 months follow up
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)	The Patient-Reported Spectacle Independence Questionnaire (PRSIQ) is comprised of 3 questions about the need for glasses or contacts in the past 7 days for distance vision (at least 1.5 meters (m) away), intermediate vision (0.5 m to 1.5 m away), and near vision (< 0.5 m away). Possible scores range from 1 to 5, with 1 = All of the time and 5 = None of the time for six of the questions; 3 of these questions ask the question in a positive way and 3 of the question ask the question in a negative way, so the higher scores are better for the negative question and are worse for the positive question. There are also 3 questions whether glasses or contacts were needed in the past 7 days with scores of Yes = 1 and No = 2. The results for each question will be summarized separately.	12 months follow up
Near Activity Visual Questionnaire (NAVQ)	The Near Activity Visual Questionnaire (NAVQ) is comprised of 10 questions about performing activities without extra reading spectacles. Each question has responses of 0 to 4, with 0 indicating 'No difficulty' and 4 indicating 'Extreme difficulty'. Any 'Not applicable' responses are scored according to the median overall score for the subject. The scores are summed with total score ranging from 0 to 30. Higher scores indicate more difficulty performing specified activities without spectacles.	12 months follow up

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Robert Ang, MD, Asian Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2020
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: BL1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No