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OpenTrials
Completed

NCT Number: NCT04617080

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Eye Institute

Makati City, Philippines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • ocular comorbidity

Treatment and study plan

SUPRACOR Regular

Procedure

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 Strong

Procedure

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 outcomes

  1. Binocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 3 months follow up

    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 outcomes

  1. Monocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 3 months follow up

    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.

  2. Monocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 3 months follow up

    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. Binocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 3 months follow up

    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.

  4. Monocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 3 months follow up

    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.

  5. Binocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 3 months follow up

    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.

  6. Monocular Uncorrected Near Visual Acuity (UNVA)

    Time frame: 3 months follow up

    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.

  7. Binocular Uncorrected Near Visual Acuity (UNVA)

    Time frame: 3 months follow up

    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.

  8. Binocular Defocus Curve

    Time frame: 3 months follow up

    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.

  9. Binocular Contrast sensitivity

    Time frame: 3 months follow up

    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.

  10. Halo Photic phenomena

    Time frame: 3 months follow up

    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.

  11. Glare Photic phenomena

    Time frame: 3 months follow up

    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. Patient-Reported Spectacle Independence Questionnaire (PRSIQ)

    Time frame: 3 months follow up

    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.

  13. Near Activity Visual Questionnaire (NAVQ)

    Time frame: 3 months follow up

    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.

Other outcomes

  1. Binocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 12 months follow up

    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.

  2. Monocular Uncorrected Distance Visual Acuity (UDVA)

    Time frame: 12 months follow up

    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. Monocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 12 months follow up

    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.

  4. Binocular Corrected Distance Visual Acuity (CDVA)

    Time frame: 12 months follow up

    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.

  5. Monocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 12 months follow up

    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.

  6. Binocular Uncorrected Intermediate Visual Acuity (UIVA)

    Time frame: 12 months follow up

    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.

  7. Monocular Uncorrected Near Visual Acuity (UNVA)

    Time frame: 12 months follow up

    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.

  8. Binocular Uncorrected Near Visual Acuity (UNVA)

    Time frame: 12 months follow up

    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.

  9. Binocular Defocus Curve

    Time frame: 12 months follow up

    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.

  10. Binocular Contrast sensitivity

    Time frame: 12 months follow up

    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.

  11. Halo Photic phenomena

    Time frame: 12 months follow up

    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. Glare Photic phenomena

    Time frame: 12 months follow up

    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.

  13. Patient-Reported Spectacle Independence Questionnaire (PRSIQ)

    Time frame: 12 months follow up

    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.

  14. Near Activity Visual Questionnaire (NAVQ)

    Time frame: 12 months follow up

    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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Nov 5, 2020
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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