Wave-Front Optimized vs Topography-Guided Ablation for Refractive Surgery

Overseen By AMBER MARTIN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: 59th Medical Wing

Disqualifiers: Prior ocular surgeries, Dry eyes, Hyperopia, others

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

Compensation: Varies

Number of Visits: 7

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods for laser eye surgery to determine which provides better vision results. One eye of each participant will receive treatment with a wave-front optimized method, while the other will undergo a topography-guided method. The trial targets individuals considering PRK or LASIK surgery who have not had previous eye surgeries or conditions like dry eyes. Participants must live within 60 miles of the trial site and be available for follow-up visits for at least 6 months. As an unphased trial, it offers participants the chance to contribute to advancements in laser eye surgery techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these ablation techniques are safe for refractive surgery?

Research has shown that both topography-guided (TG) and wave-front optimized (WFO) treatments for eye surgery are generally safe and well-tolerated.

Topography-guided ablation has proven safe and effective for correcting vision problems such as nearsightedness and astigmatism, which cause blurry vision. Studies have found that patients often achieve good results with this method, making it a reliable way to improve vision.

Wave-front optimized ablation is also very safe. One study found that many patients achieved excellent vision without needing glasses or contacts after surgery, demonstrating its effectiveness in improving vision while maintaining safety.

Both treatments are used in surgeries like PRK and LASIK and have shown similar safety results. Prospective participants in the clinical trial can feel confident about the safety of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because topography-guided (TG) ablation and Wave-Front Optimized (WFO) ablation offer personalized approaches to refractive surgery, which aims to improve vision. Unlike traditional laser surgeries that use a one-size-fits-all method, TG ablation customizes the laser treatment based on the unique shape of each patient's cornea, potentially enhancing visual outcomes and reducing side effects. WFO ablation, on the other hand, is designed to minimize the induction of higher-order aberrations by optimizing the wavefront of the laser beam, which may result in clearer and sharper vision compared to conventional methods. These innovations could lead to more precise corrections and better overall satisfaction for patients undergoing procedures like PRK and LASIK.

What evidence suggests that these ablation techniques are effective for refractive surgery?

This trial will compare topography-guided (TG) ablation with wave-front optimized (WFO) ablation in refractive surgery. Research has shown that TG ablation in vision correction surgery often leads to better results, reducing vision problems and improving clarity, especially for individuals with certain corneal issues. One study found TG ablation safer and more effective than regular methods for correcting vision errors after some corneal surgeries.

Meanwhile, studies have shown that WFO ablation works well for individuals with myopia (nearsightedness) and effectively fine-tunes vision after previous surgeries like LASIK. Both TG and WFO ablations offer benefits, and research supports their effectiveness in improving eyesight. Participants in this trial will be randomized to receive either TG or WFO ablation to assess their comparative effectiveness. ^{1 6 7 8 9}

Who Is on the Research Team?

CHARISMA B EVANGELISTA, MD

Principal Investigator

59th Medical Wing

Are You a Good Fit for This Trial?

This trial is for people aged 21-50 who are eligible for PRK or LASIK eye surgery, have had stable vision with less than a half diopter change, and can attend follow-ups. They must live within 60 miles of the clinic and stay in the area for at least six months post-surgery. Those with certain eye conditions, previous surgeries, or women who are pregnant/breastfeeding cannot participate.

Inclusion Criteria

DOD beneficiaries age 21-50 years

Meet requirements for PRK or LASIK i.e., Stable <= .5 D change MRSE)

Willing to complete all required follow-up visits

Exclusion Criteria

No meeting requirements for PRK or LASIK

History of herpetic disease

You are breastfeeding at any point during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Evaluation

Standard preoperative evaluation including vision assessments, contrast sensitivity, and keratometry

1-3 hours

1 visit (in-person)

Surgery

Patients undergo LASIK or PRK surgery with either Wave-Front Optimized or Topography-guided ablation

1 day

1 visit (in-person)

Post-operative Care

Standard post-operative care with evaluations at day 1, week 1, month 1, month 3, and month 6

6 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Topography-guided (TG) ablation
• Wave-Front Optimized (WFO) ablation

Trial Overview The study compares two types of laser eye surgery: Wave-Front Optimized (WFO) ablation and Topography-guided (TG) ablation during PRK or LASIK procedures. It's designed to see which method gives better visual results by treating one eye with WFO and the other with TG randomly.

How Is the Trial Designed?

Group I: PRK refractive surgery Experimental Treatment 1 Intervention

Contralateral Randomize Wave-Front Optimized (WFO) ablation vs Topography-guided ablation

Group II: LASIK refractive surgery Experimental Treatment 1 Intervention

Contralateral Randomize Wave-Front Optimized (WFO) ablation vs Topography-guided ablation

Who Is Running the Clinical Trial?

59th Medical Wing

Lead Sponsor

Trials

42

Recruited

12,700+

Published Research Related to This Trial

In a study of 46 eyes from 23 myopic patients, both topography-guided customized ablation treatment (TCAT) and wavefront-optimized (WFO) photorefractive keratectomy (PRK) resulted in similar visual outcomes, with 96% of eyes achieving 20/20 vision or better after 12 months.

Both treatments demonstrated comparable safety and efficacy, with no significant differences in postoperative complications or visual quality, although TCAT showed a lower magnitude of higher order aberrations, which was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes Comparison Between Wavefront-Optimized and Topography-Guided PRK in Contralateral Eyes With Myopia and Myopic Astigmatism. Faria-Correia, F., Ribeiro, S., Lopes, BT., et al.[2021]

In a study of 32 patients undergoing LASIK for myopia, both wavefront-optimized (WFO) ablation and topography-guided Contoura ablation (TGCA) resulted in similar visual outcomes, with no significant differences in uncorrected and corrected distance visual acuity.

However, TGCA was associated with significantly lower levels of vertical and horizontal coma and required less stromal tissue ablation compared to WFO, suggesting it may be a safer option with potentially fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Wavefront-Optimized Ablation and Topography-Guided Contoura Ablation With LYRA Protocol in LASIK. Ozulken, K., Yuksel, E., Tekin, K., et al.[2019]

In a study of 432 eyes from 216 myopic patients, topography-guided customized ablation treatment (TCAT) resulted in fewer higher order aberrations and less optical path difference compared to wavefront-optimized (WFO) LASIK at both 1 and 6 months post-surgery.

However, TCAT was less effective in accurately correcting astigmatism compared to WFO LASIK, indicating a need for improved methods to enhance TCAT's precision in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Comparative Study of Topography-Guided Versus Wavefront-Optimized FS-LASIK for Correcting Myopia and Myopic Astigmatism. Zhang, Y., Chen, Y.[2020]

A meta-analysis of seven randomized controlled trials involving 1,168 eyes found that both topography-guided customized ablation treatment (TCAT) and wavefront-optimized (WFO) LASIK are effective and safe for treating myopia, with no significant difference in achieving 20/20 or better vision.

TCAT-LASIK showed superior predictability in achieving the target refractive outcome and resulted in fewer surgically induced higher order aberrations compared to WFO-LASIK, indicating it may provide better visual quality post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topography-Guided Versus Wavefront-Optimized LASIK for Myopia With and Without Astigmatism: A Meta-analysis. Cheng, SM., Tu, RX., Li, X., et al.[2021]

In a study of 84 patients undergoing LASIK for myopia, topography-guided ablation resulted in better uncorrected visual acuity compared to wavefront-optimized ablation six months post-surgery (P = .02).

Topography-guided ablation also led to a reduction in higher order aberrations (HOAs), indicating a potentially safer and more effective option for minimizing visual disturbances after LASIK, although the difference in total HOAs was not statistically significant (P = .51).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wavefront-optimized ablation versus topography-guided customized ablation in myopic LASIK: comparative study of higher order aberrations. El Awady, HE., Ghanem, AA., Saleh, SM.[2022]

A systematic review of 11 studies involving 1425 eyes found that both topography-guided (TG) and wavefront-optimized (WFO) LASIK are safe and effective for treating myopia, with no significant differences in achieving 20/20 vision or other visual outcomes.

However, TG-LASIK showed superior precision, with a higher proportion of patients achieving target refraction within ±0.5 diopter and lower levels of higher-order aberrations compared to WFO-LASIK.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual differences in topography-guided versus wavefront-optimized LASIK in the treatment of myopia: a Meta-analysis. Hu, PC., Li, L., Wu, XH., et al.[2021]

In a study of 195 patients undergoing LASIK for myopia and myopic astigmatism, all three techniques (TMR-LASIK, WFO-LASIK, and manifest TG-LASIK) achieved similar uncorrected distance visual acuity (UDVA) outcomes three months post-surgery.

However, TMR-LASIK resulted in significantly higher residual astigmatism compared to WFO and manifest TG-LASIK, indicating that while all methods were effective, TMR-LASIK may not be as precise in correcting astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes after topography-modified refraction versus wavefront-optimized versus manifest topography-guided LASIK. Kim, J., Choi, SH., Lim, DH., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11182089/

Topography-guided excimer laser ablation in refractive surgery This review will explore the principles, clinical applications, outcomes, and comparative analyses associated with Topo-G excimer laser ablation.

2. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03593-5

Clinical outcomes after topography-guided FS-LASIK for ... Topography guided ablation with PAE algorithms for patients with zero manifest astigmatism demonstrated better results in correcting corneal ...

3. mdpi.com mdpi.com/2077-0383/14/4/1038

Efficacy of Photorefractive Keratectomy vs. Topography- ... Topography-guided PRK is safer and more effective in correcting aberrations and refractive errors after corneal keratoplasty than regular PRK.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10540697/

A Prospective Study Evaluating Patient-Reported Outcomes In this study, the authors evaluate patient-reported outcomes with the PROWL questionnaire before and after undergoing TG-LASIK using the Phorcides analytic ...

5. link.springer.com link.springer.com/article/10.1007/s40123-025-01245-5

Comparison of U.S. FDA Premarket Approval Studies ... Visual and refractive outcomes of two FDA PMA studies were compared: (1) topography-guided LASIK performed with the Allegretto Wave Eye-Q ...

6. ascrs.org ascrs.org/clinical-education/presentations-on-demand/2020/2020-sps-215-refractive-procedure-outcomes-prk-lvc-lasik

SPS-215 Refractive Procedure Outcomes: PRK, LVC, LASIK Topography-guided LASIK is safe, effective and predictable in the treatment of patients with myopia and compound myopic astigmatism. Progressive changes in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452403420300121

Topography guided custom ablation treatment for residual ... In this study, we report the safety and outcomes of TCAT in the treatment of residual refractive error and astigmatism after keratoplasty for keratoconus.

8. americanrefractivesurgerycouncil.org americanrefractivesurgerycouncil.org/lasik-laser-eye-surgery-research/

References: LASIK Clinical Research The FDA's Patient Reported Outcomes with LASIK (PROWL), published in 2017, is a definitive study examining the patient experience with LASIK laser eye surgery.

9. journals.lww.com journals.lww.com/ijo/fulltext/2024/72110/clinical_outcomes_of_topography_guided_versus.12.aspx

Clinical outcomes of topography-guided versus wavefront ... Purpose: To compare the safety, efficacy, and visual outcomes of topography-guided (TG) LASIK ablation versus advanced ablation algorithm (AAA) on Zeiss Mel ...