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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ametropia

Intervention / Treatment
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* Procedure: SUPRACOR Regular
* Procedure: SUPRACOR Strong


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presbyopia willingness for a refractive presbyopia correction signed informed consent form Exclusion Criteria: - ocular comorbidity

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SUPRACOR Regular<br> | Procedure: SUPRACOR Regular<br>* 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.<br>|
| Experimental: SUPRACOR Strong<br> | Procedure: SUPRACOR Strong<br>* 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.<br>|

What is the study measuring?
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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 |