SMILE vs. LASIK Using Contoura With Phorcides

Myopia Clinical Trial

Official title:

Comparison of Clinical Outcomes of SMILE vs. LASIK Using Contoura With Phorcides

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05844397
• Other study ID #: C.2023.052
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: May 14, 2024

Study information

• Verified date: April 2023
• Source: 59th Medical Wing
• Contact: Jose E Capo-Aponte, OD. PhD
• Phone: 210-292-2554
• Email: Jose.E.CapoAponte.ctr[@]health.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects will undergo SMILE surgery in one eye and LASIK using Contoura with Phorcides on the contralateral eye to correct myopia.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: May 14, 2024
• Est. primary completion date: May 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• WaveLight EX500 Excimer Laser System
LASIK Refractive Surgery Using Contura with Phorcides
• VisuMax Surgical Laser
SMILE Refractive Surgery

Locations

Country	Name	City	State
United States	Wilford Hall Ambulatory Surgical Center	Lackland Air Force Base	Texas

Sponsors (1)

Lead Sponsor	Collaborator
59th Medical Wing

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in low contrast visual acuity at 6-month Post-Op	Change in the mean low contrast visual acuity (unit = logMAR) measure with ETDRS 5% chart from baseline (pre-op) at 6 months post-op.	Change from baseline (pre-op) to 6-month Post-Op
Other	Change in higher order aberrations at 6-month Post-Op	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.	Changes from baseline (pre-op) to 6-month Post-Op
Other	Change in mean score Patient-Reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) Questionnaire at 6-month Post-Op	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.	Changes from baseline (pre-op) to 6-month Post-Op
Other	Change in mean score Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire at 6-month Post-Op	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.	Changes from baseline (pre-op) to 6-month Post-Op
Primary	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	6-month Post-Op
Secondary	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 from baseline (pre-op) to 6-month Post-Op
Secondary	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.	Change from baseline (pre-op) to 6-month Post-Op