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

Primary Purpose

Ametropia

Status
Recruiting
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
SUPRACOR Regular
SUPRACOR Strong
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ametropia

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

- ocular comorbidity

Sites / Locations

  • Asian Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SUPRACOR Regular

SUPRACOR Strong

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 30, 2020
Last Updated
May 7, 2023
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT04617080
Brief Title
Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm
Official Title
Prospective Clinical Study to Evaluate the Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SUPRACOR Regular
Arm Type
Active Comparator
Arm Title
SUPRACOR Strong
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
SUPRACOR Regular
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
SUPRACOR Strong
Intervention Description
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.
Primary Outcome Measure Information:
Title
Binocular Uncorrected Distance Visual Acuity (UDVA)
Description
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.
Time Frame
3 months follow up
Secondary Outcome Measure Information:
Title
Monocular Uncorrected Distance Visual Acuity (UDVA)
Description
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.
Time Frame
3 months follow up
Title
Monocular Corrected Distance Visual Acuity (CDVA)
Description
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.
Time Frame
3 months follow up
Title
Binocular Corrected Distance Visual Acuity (CDVA)
Description
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.
Time Frame
3 months follow up
Title
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Description
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.
Time Frame
3 months follow up
Title
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Description
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.
Time Frame
3 months follow up
Title
Monocular Uncorrected Near Visual Acuity (UNVA)
Description
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.
Time Frame
3 months follow up
Title
Binocular Uncorrected Near Visual Acuity (UNVA)
Description
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.
Time Frame
3 months follow up
Title
Binocular Defocus Curve
Description
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.
Time Frame
3 months follow up
Title
Binocular Contrast sensitivity
Description
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.
Time Frame
3 months follow up
Title
Halo Photic phenomena
Description
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.
Time Frame
3 months follow up
Title
Glare Photic phenomena
Description
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.
Time Frame
3 months follow up
Title
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
Description
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.
Time Frame
3 months follow up
Title
Near Activity Visual Questionnaire (NAVQ)
Description
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.
Time Frame
3 months follow up
Other Pre-specified Outcome Measures:
Title
Binocular Uncorrected Distance Visual Acuity (UDVA)
Description
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.
Time Frame
12 months follow up
Title
Monocular Uncorrected Distance Visual Acuity (UDVA)
Description
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.
Time Frame
12 months follow up
Title
Monocular Corrected Distance Visual Acuity (CDVA)
Description
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.
Time Frame
12 months follow up
Title
Binocular Corrected Distance Visual Acuity (CDVA)
Description
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.
Time Frame
12 months follow up
Title
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Description
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.
Time Frame
12 months follow up
Title
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Description
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.
Time Frame
12 months follow up
Title
Monocular Uncorrected Near Visual Acuity (UNVA)
Description
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.
Time Frame
12 months follow up
Title
Binocular Uncorrected Near Visual Acuity (UNVA)
Description
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.
Time Frame
12 months follow up
Title
Binocular Defocus Curve
Description
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.
Time Frame
12 months follow up
Title
Binocular Contrast sensitivity
Description
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.
Time Frame
12 months follow up
Title
Halo Photic phenomena
Description
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.
Time Frame
12 months follow up
Title
Glare Photic phenomena
Description
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.
Time Frame
12 months follow up
Title
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
Description
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.
Time Frame
12 months follow up
Title
Near Activity Visual Questionnaire (NAVQ)
Description
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.
Time Frame
12 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presbyopia willingness for a refractive presbyopia correction signed informed consent form Exclusion Criteria: - ocular comorbidity
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Williart, MD
Phone
+33(0)6 27 38 17 67
Email
anne.williart@bausch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ang, MD
Organizational Affiliation
Asian Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asian Eye Institute
City
Makati City
Country
Philippines
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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