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SMILE vs. LASIK Using Contoura With Phorcides

Primary Purpose

Myopia, Astigmatism

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WaveLight EX500 Excimer Laser System
VisuMax Surgical Laser
Sponsored by
59th Medical Wing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring SMILE, LASIK, Countoura, Phorcides

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and Females between the ages of 21 and 50 Nearsightedness between -2.00 diopters and -8.00 diopters Have similar levels of nearsightedness in each eye (≤1.5D of difference between eyes) Less than or equal to 3.00 diopters of astigmatism Have similar levels of astigmatism in each eye (≤0.75D of difference between eyes) Total spherical equivalent (SE) of no more than -8.0 D Tricare Prime Beneficiary Residing within 60 miles radius from Lackland AFB Exclusion Criteria: Subjects with corneal abnormal findings including signs of keratoconus, keratoconus suspect, abnormal corneal topography, epithelial basement membrane disease, pellucid marginal degeneration, corneal degenerations, progressive and unstable myopia, irregular or unstable corneal mires on central keratometry images, and patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma from the corneal endothelium. Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases Pregnant or nursing females Systemic disease likely to affect wound healing, such as uncontrolled diabetes and severe atopy Any ocular disease such as advanced/uncontrolled glaucoma, severe dry eye, active eye infection or inflammation, recent herpes eye infection or problems resulting from past infection. 0.25 or 0.50 of manifest astigmatism in either eye Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.

Sites / Locations

  • Wilford Hall Ambulatory Surgical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LASIK using Contoura with Phorcides

SMILE

Arm Description

LASIK using Contoura with Phorcides in one eye.

small incision lenticule extraction (SMILE) refractive surgery on the contralateral eye.

Outcomes

Primary Outcome Measures

Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op
Post-operative uncorrected visual acuity of 20/16 or better measure with ETDRS chart; unit = percentage eyes with Uncorrected Visual Acuity

Secondary Outcome Measures

Change in high contrast visual acuity at 6-month Post-Op
Change in the mean uncorrected visual acuity (unit = logMAR) measure with ETDRS chart from baseline (pre-op) at 6 months post-op.
Change in refractive error at 6-month Post-Op
Change in the mean refractive error measure with phoropter (unit = diopters) from baseline (pre-op) at 6 months post-op.

Full Information

First Posted
April 21, 2023
Last Updated
May 3, 2023
Sponsor
59th Medical Wing
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1. Study Identification

Unique Protocol Identification Number
NCT05844397
Brief Title
SMILE vs. LASIK Using Contoura With Phorcides
Official Title
Comparison of Clinical Outcomes of SMILE vs. LASIK Using Contoura With Phorcides
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
May 14, 2024 (Anticipated)
Study Completion Date
May 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
59th Medical Wing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.
Detailed Description
Once consented to participate in the study, subjects will have a comprehensive ocular examination to determine eligibility to undergo simultaneous SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.The study objective is to compare the 6-month visual outcomes (i.e., visual acuity, contract sensitivity, high order aberrations), quality of vision (i.e., double vision, glare, starburst, halos, etc.) and dry eye symptoms of patients undergoing contralateral LASIK using Contoura with Phorcides and SMILE surgery. Surgical treatment will be randomized so there is a 50% chance to receive SMILE on the right eye and LASIK on the contralateral eye. Subjects will receive standard of care topical ophthalmic antibiotic and steroid drops. Visual outcomes and patient self-reported symptoms will be assessed at week 2, month 1, month 3, and month 6.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
Keywords
SMILE, LASIK, Countoura, Phorcides

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized contralateral study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LASIK using Contoura with Phorcides
Arm Type
Active Comparator
Arm Description
LASIK using Contoura with Phorcides in one eye.
Arm Title
SMILE
Arm Type
Active Comparator
Arm Description
small incision lenticule extraction (SMILE) refractive surgery on the contralateral eye.
Intervention Type
Device
Intervention Name(s)
WaveLight EX500 Excimer Laser System
Intervention Description
LASIK Refractive Surgery Using Contura with Phorcides
Intervention Type
Device
Intervention Name(s)
VisuMax Surgical Laser
Intervention Description
SMILE Refractive Surgery
Primary Outcome Measure Information:
Title
Percentage of eyes with Uncorrected Visual Acuity of 20/16 or better at 6-month Post-Op
Description
Post-operative uncorrected visual acuity of 20/16 or better measure with ETDRS chart; unit = percentage eyes with Uncorrected Visual Acuity
Time Frame
6-month Post-Op
Secondary Outcome Measure Information:
Title
Change in high contrast visual acuity at 6-month Post-Op
Description
Change in the mean uncorrected visual acuity (unit = logMAR) measure with ETDRS chart from baseline (pre-op) at 6 months post-op.
Time Frame
Change from baseline (pre-op) to 6-month Post-Op
Title
Change in refractive error at 6-month Post-Op
Description
Change in the mean refractive error measure with phoropter (unit = diopters) from baseline (pre-op) at 6 months post-op.
Time Frame
Change from baseline (pre-op) to 6-month Post-Op
Other Pre-specified Outcome Measures:
Title
Change in low contrast visual acuity at 6-month Post-Op
Description
Change in the mean low contrast visual acuity (unit = logMAR) measure with ETDRS 5% chart from baseline (pre-op) at 6 months post-op.
Time Frame
Change from baseline (pre-op) to 6-month Post-Op
Title
Change in higher order aberrations at 6-month Post-Op
Description
Change in the mean higher order aberrations (unit = root mean square) measure with iDesign 2.0 Refractive Studio from baseline (pre-op) at 6 months post-op.
Time Frame
Changes from baseline (pre-op) to 6-month Post-Op
Title
Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op
Description
The PROWL-SS is a validated tool to assess self-reported symptoms and satisfaction after refractive surgery. Possible Satisfaction Score ranges from 1 (completely satisfied) to 6 (completely dissatisfied). Lower value indicates higher satisfaction. Possible Symptoms Score ranges from 1 (extremely bothersome) to 5 (not at all bothersome). Lower value indicates worse symptoms.
Time Frame
Changes from baseline (pre-op) to 6-month Post-Op
Title
Change in mean score Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire at 6-month Post-Op
Description
The SPEED is a validated tool to assess self-reported dry eye symptoms. Possible dry eye symptoms score ranges from 0 (never) to 3 (Constant). Higher value indicates worse dry eye symptoms.
Time Frame
Changes from baseline (pre-op) to 6-month Post-Op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Females between the ages of 21 and 50 Nearsightedness between -2.00 diopters and -8.00 diopters Have similar levels of nearsightedness in each eye (≤1.5D of difference between eyes) Less than or equal to 3.00 diopters of astigmatism Have similar levels of astigmatism in each eye (≤0.75D of difference between eyes) Total spherical equivalent (SE) of no more than -8.0 D Tricare Prime Beneficiary Residing within 60 miles radius from Lackland AFB Exclusion Criteria: Subjects with corneal abnormal findings including signs of keratoconus, keratoconus suspect, abnormal corneal topography, epithelial basement membrane disease, pellucid marginal degeneration, corneal degenerations, progressive and unstable myopia, irregular or unstable corneal mires on central keratometry images, and patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma from the corneal endothelium. Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases Pregnant or nursing females Systemic disease likely to affect wound healing, such as uncontrolled diabetes and severe atopy Any ocular disease such as advanced/uncontrolled glaucoma, severe dry eye, active eye infection or inflammation, recent herpes eye infection or problems resulting from past infection. 0.25 or 0.50 of manifest astigmatism in either eye Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose E Capo-Aponte, OD. PhD
Phone
210-292-2554
Email
Jose.E.CapoAponte.ctr@health.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Charisma B Evangelista, MD
Phone
210-292-4700
Email
charisma.b.evangelista.mil@health.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charisma B Evangelista, MD
Organizational Affiliation
59th Medical Wing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilford Hall Ambulatory Surgical Center
City
Lackland Air Force Base
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose E Capo-Aponte, OD, PhD
Phone
210-292-2554
Email
Jose.E.CapoAponte.ctr@health.mil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36539217
Citation
Ma KK, Manche EE. Patient-reported quality of vision in a prospective randomized contralateral-eye trial comparing LASIK and small-incision lenticule extraction. J Cataract Refract Surg. 2023 Apr 1;49(4):348-353. doi: 10.1097/j.jcrs.0000000000001127.
Results Reference
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SMILE vs. LASIK Using Contoura With Phorcides

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