LASIK iDesign vs SMILE for Vision Correction

(TG-LASIK vs SM Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: 59th Medical Wing

Must not be taking: Isotretinoin, Antimetabolites

Disqualifiers: Corneal abnormalities, Autoimmune diseases, Pregnancy, Diabetes, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of vision correction surgeries: LASIK using iDesign and SMILE. Researchers seek to determine which procedure provides better vision and reduces dryness or glare after six months. Individuals with nearsightedness between -2.00 and -8.00 diopters and astigmatism up to 3.00 diopters may qualify if they have similar vision in both eyes and reside near Lackland AFB. Participants must also have military health insurance (Tricare Prime/Select). As an unphased trial, this study offers participants the opportunity to contribute to the advancement of vision correction options.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking Isotretinoin (Accutane) or antimetabolites.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that LASIK using iDesign is safe and effective. Most patients report satisfaction with their vision post-surgery, and many would recommend it to others. The FDA has approved the iDesign system, confirming its safety.

Research also shows that SMILE surgery is safe and effective. Five years after surgery, studies confirm SMILE's strong safety record. Both SMILE and LASIK are common procedures with proven safety in the U.S. Military.

These treatments have been widely used and are generally well-tolerated. However, like any surgery, some side effects may occur. These might include glare or halos around lights, but most people find these minor compared to the benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LASIK iDesign and SMILE for vision correction because they offer innovative approaches compared to standard LASIK procedures. LASIK iDesign uses advanced wavefront technology to create a highly detailed map of the eye, allowing for more personalized treatment that could result in sharper vision. SMILE, on the other hand, is a minimally invasive procedure that involves removing a small piece of corneal tissue through a tiny incision, which may lead to faster recovery and less discomfort. Both treatments aim to enhance precision and comfort, potentially setting new benchmarks in vision correction.

What evidence suggests that this trial's treatments could be effective for vision correction?

This trial will compare LASIK using iDesign with SMILE for vision correction. Research has shown that LASIK using iDesign effectively improves vision, with studies indicating that 95.4% of patients are satisfied with their results, and most achieve 20/40 vision or better within six months. LASIK also enhances eyesight and reduces the need for glasses or contact lenses.

Meanwhile, long-term studies have confirmed that SMILE surgery is safe and effective, particularly for correcting nearsightedness. Patients often notice improved vision within 24 hours and experience minimal discomfort. The smaller incision in SMILE surgery reduces the risk of infection, making it a reliable choice for vision correction. ^{3 4 6 7 8}

Who Is on the Research Team?

Charisma B Evangelista, MD

Principal Investigator

Joint Warfighter Refractive Surgery Center, Wilford Hall Ambulatory Surgical Center

Are You a Good Fit for This Trial?

This trial is for individuals with mixed astigmatism or near-sightedness who want to correct their vision. Participants will undergo two different laser eye surgeries on each eye. Those with certain eye conditions, previous eye surgeries, or other specific health issues may not be eligible.

Inclusion Criteria

Total spherical equivalent (SE) of no more than -8.0 D

Tricare Prime/Select Beneficiary (military health insurance)

My astigmatism is 3.00 diopters or less.

Exclusion Criteria

Potential candidate who cannot provide Informed Consent will not be allowed to participate

I do not have conditions like uncontrolled diabetes that could affect wound healing.

I do not have severe eye conditions like uncontrolled glaucoma or recent infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo simultaneous SMILE surgery in one eye and LASIK using iDesign on the contralateral eye to correct myopia

1 day

1 visit (in-person)

Follow-up

Visual outcomes and patient self-reported symptoms are assessed

6 months

5 visits (in-person) at day 1, week 2, month 1, month 3, and month 6

What Are the Treatments Tested in This Trial?

Interventions

• LASIK iDesign
• SMILE

Trial Overview The study compares visual outcomes and quality of vision between two laser surgeries: LASIK using the STAR S4 IR Excimer Laser System on one eye and SMILE surgery using the VisuMax 400 Surgical Laser on the other, over a period of six months.

How Is the Trial Designed?

Group I: SMILE Experimental Treatment 1 Intervention

SMILE Refractive Surgery

Group II: LASIK using iDesign Active Control 1 Intervention

LASIK guided by iDesign

Who Is Running the Clinical Trial?

59th Medical Wing

Lead Sponsor

Trials

42

Recruited

12,700+

United States Army Aeromedical Research Laboratory

Collaborator

Trials

5

Recruited

270+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4302464/

Functional Outcome and Patient Satisfaction after Laser In Situ ... Based on this review, worldwide, an average 95.4% of patients were satisfied with their outcome after LASIK surgery. With 16.3 million procedures performed ...

2. journals.lww.com journals.lww.com/atmr/fulltext/2024/07000/long_term_clinical_outcomes_of_lasik_surgery.26.aspx

Long-term Clinical Outcomes of LASIK Surgery Across ... The study confirmed the efficiency of LASIK, which provides stable positive outcomes in increasing visual acuity and decreasing the requirement of optical aids ...

3. dovepress.com dovepress.com/comparison-and-analysis-of-fda-reported-visual-outcomes-of-the-three-l-peer-reviewed-fulltext-article-OPTH

Comparison and analysis of FDA reported visual outcomes ... In at least 90% of treated eyes at 3 months and 12 months, all three lasers showed either no change or a gain of corrected distance visual ...

4. lasikcenternj.com lasikcenternj.com/laser-vision-correction/lasik/idesign-advanced-wavescan-studio-system/

Custom LASIK - iDesign - Whippany, NJ - Essex County, NJ Today, LASIK is safer, quicker, and more effective than ever. What do we have to thank? Technologies like the iDesign Advanced WaveScan Studio System. At Laser ...

5. assileye.com assileye.com/blog/idesign-lasik-vs-contoura-vision-lasik/

iDesign® LASIK vs Contoura® Vision LASIK The study found that 100% of patients achieved visual acuity of 20/40 or better at six months postoperative, indicating a high success rate for ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P930016S044b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The safety and effectiveness of wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced WaveScan Studio System and STAR S4 IR ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07126756

Study Details | NCT07126756 | LASIK iDesign vs SMILE Both SMILE and LASIK treatments are FDA-approved and are both performed routinely as standard of care surgery in the US Military. However, there ...

8. eyenm.com eyenm.com/lasik-albuquerque/lasik-idesign-technology/

LASIK iDesign Technology iDesign Technology is an advanced wavefront-guided system designed to map the unique imperfections of your eye, mainly used in LASIK procedures.