NCT04617080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

4.1 years

First QC Date

October 30, 2020

Last Update Submit

February 29, 2024

Conditions

Ametropia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Monocular Uncorrected Distance Visual Acuity (UDVA)

    3 months follow up

  • Monocular Corrected Distance Visual Acuity (CDVA)

    3 months follow up

  • Binocular Corrected Distance Visual Acuity (CDVA)

    3 months follow up

  • Monocular Uncorrected Intermediate Visual Acuity (UIVA)

    3 months follow up

  • Binocular Uncorrected Intermediate Visual Acuity (UIVA)

    3 months follow up

  • +8 more secondary outcomes

Other Outcomes (14)

  • Binocular Uncorrected Distance Visual Acuity (UDVA)

    12 months follow up

  • Monocular Uncorrected Distance Visual Acuity (UDVA)

    12 months follow up

  • Monocular Corrected Distance Visual Acuity (CDVA)

    12 months follow up

  • +11 more other outcomes

Study Arms (2)

SUPRACOR Regular

ACTIVE COMPARATOR
Procedure: SUPRACOR Regular

SUPRACOR Strong

EXPERIMENTAL
Procedure: SUPRACOR Strong

Interventions

SUPRACOR RegularPROCEDURE

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 Regular
SUPRACOR StrongPROCEDURE

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.

SUPRACOR Strong

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- ocular comorbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Eye Institute

Makati City, Philippines

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Robert Ang, MD

    Asian Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 5, 2020

Study Start

January 26, 2020

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Locations

PH(1)