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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
Asian Eye Institute
Makati City, Philippines
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.
Time frame: 3 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months follow up