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

Trial Summary

What is the purpose of this trial?

This is a prospective randomized contralateral double-masked study. Each patient will be randomized as to which eye undergoes wave-front optimized (WFO) vs. wave-front guided (WFG) during Photorefractive keratectomy (PRK) or Laser-assisted in situ Keratomileusis (LASIK) surgery to determine which ablation profile provides the best visual outcome.

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 data supports the effectiveness of the treatment Topography-guided (TG) ablation and Wave-Front Optimized (WFO) ablation for refractive surgery?

Research comparing topography-guided and wavefront-optimized LASIK for myopia shows both treatments are effective, with some studies indicating differences in visual outcomes and aberrations (imperfections in the eye's optical system). These findings suggest that both methods can successfully correct vision, but may offer slightly different benefits depending on individual eye characteristics. ^{1 2 3 4 5}

Is Wave-Front Optimized and Topography-Guided Ablation safe for refractive surgery?

Research comparing Wave-Front Optimized and Topography-Guided Ablation for LASIK surgery in treating myopia and astigmatism generally focuses on visual outcomes and safety. These studies suggest that both methods are safe for correcting vision issues like myopia, with no significant safety concerns reported. ^{1 2 4 5 6}

How does topography-guided ablation differ from wavefront-optimized ablation in refractive surgery?

Topography-guided ablation customizes the laser treatment based on the unique shape of the cornea, potentially offering more precise correction for vision issues, while wavefront-optimized ablation focuses on reducing visual distortions by considering the eye's overall wavefront (light path) characteristics. ^{1 2 3 4 7}

Research Team

CHARISMA B EVANGELISTA, MD

Principal Investigator

59th Medical Wing

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

Visual differences in topography-guided versus wavefront-optimized LASIK in the treatment of myopia: a Meta-analysis. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of Wavefront-Optimized Ablation and Topography-Guided Contoura Ablation With LYRA Protocol in LASIK. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Wavefront-optimized ablation versus topography-guided customized ablation in myopic LASIK: comparative study of higher order aberrations. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of outcomes after topography-modified refraction versus wavefront-optimized versus manifest topography-guided LASIK. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Topography-Guided Versus Wavefront-Optimized LASIK for Myopia With and Without Astigmatism: A Meta-analysis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes Comparison Between Wavefront-Optimized and Topography-Guided PRK in Contralateral Eyes With Myopia and Myopic Astigmatism. [2021]