New data published in the Journal of Refractive Surgery analyzed the use of Bausch + Lomb’s TENEO excimer laser for treating myopia and myopic astigmatism laser-assisted in situ keratomileusis (LASIK) surgery.
First, a refresh on this laser.
Approved by the FDA for LASIK in January 2024, the compact-sized TENEO is marketed as the first excimer platform to be approved in the U.S. in nearly two decades, as well as the country’s smallest laser of its kind.
- Note: The platform is already available in 50+ countries across the globe, where it’s known as the “Technolas Teneo 317 (Model 2)” by Technolas Perfect Vision.
What it includes: A customizable graphical user interface (GUI) touch screen for equipping surgeons with a simplified set up process and all-in-one access to patient data (without the need for multiple screens).
- Plus: A 360° swiveling microscope adapts itself based on a surgeon’s height and posture.
What other unique features does it come with?
- Compact design of 6.8 sq ft (for optimal clinical space)
- Advanced eye-tracker (operating at 1,740 Hz—currently the fastest of all flying spot excimer lasers in the U.S.)
- High-speed (500 Hz) laser operating at an ablation time of an estimated 1.2 seconds per diopter—also currently the fastest of all similar lasers in the country
As a bonus: Watch George O. Waring IV, MD, FACS, founder and medical director of the Waring Vision Institute, discuss his clinical experience using the platform.
Now let’s talk about the study.
The prospective, multicenter, open-label, non-randomized, single-arm, pivotal study (NCT04111757) evaluated the safety and efficacy of the TENEO when used with a new aspheric ablation algorithm (PROSCAN 1.28 SW) on 168 participants (333 eyes) during LASIK surgery.
- Participant criteria: Aged 22+, diagnosed with myopia or myopia astigmatism, and a demonstration of stable refraction for at least 12 months before surgery. More details here.
- Note: Of the 333 eyes: 51 eyes were treated for spherical myopia; 282 eyes were treated for astigmatic myopia
- The setup: The TENEO was used on one or both eyes of each participant during LASIK.
And what was measured?
Two primary outcomes, both evaluated at months 3 and 9:
- Eyes achieving a manifest refraction spherical equivalent (MRSE) predictability within ±0.50 Diopter (D) and ±1.00 D
- Eyes targeted for emmetropia achieving uncorrected distance visual acuity (UDVA) of 20/40 (0.3 logMAR) or better
And the findings?
Of the 168 participants:
- 165 underwent bilateral surgery
- 3 underwent unilateral treatment
Plus: A total of 17 eyes discontinued the study, resulting in 316 analyzed at 9 months postoperative (postop).
Zero in on visual outcomes.
At 9 months postop, uncorrected and corrected DVA of 20/25 or better were seen in 97.8% and 100% of eyes, respectively. Further, no eyes lost two or more lines of CDVA.
Based on the type of refractive treatment, the following myopic eyes had a UDVA of 20/40 or better:
- 100% of spherical myopia-treated eyes
- 99.6% of astigmatic myopia-treated eyes
And in all for this timeframe?
All eyes demonstrated a CDVA of 20/50 or better, while 4.4% of eyes gained 2 or more lines of CDVA and “none of the eye lost two or more lines of CDVA at 9 months postoperatively,” the study authors noted.
Now the refractive outcomes.
Also at 9 months, 92.7% of eyes achieved a residual refractive error within ±0.50 D, while 99.1% achieved a refractive error within ±1.00 D—correspondingly, eyes treated for spherical myopia were 96.1% and 100%, respectively.
What happened with pre/postop MRSE?
Among astigmatic myopic-treated eyes, the mean preoperative (preop) MRSE improved from −5.22 ± 2.23 D at preop to −0.09 ± 0.28 D postop.
For spherical myopic-treated eyes, the mean preop MRSE improved from −5.75 ± 2.57 D at preop to −0.03 ± 0.33 D postop.
And refractive data on the whole?
Overall, results were stable, with the following percentages demonstrating a change in MRSE of 0.50 D or less:
- 1 to 3 months: 96.2%
- 3 to 6 months: 95.3%
- 6 to 9 months: 93.9%
What else?
While a total of 73.1% of eyes demonstrated improvement in astigmatism from preop to postop, 18% of eyes demonstrated no change.
As for residual refractive cylinder at 9 months postop:
- 93% showed 0.50 D or less
- 99.4% showed 1.00 D or less
So how did this data compare to previous studies?
In all, the data was noted as comparable to previous findings of topography-guided or wavefront-guided LASIK in the following categories:
- Efficacy
- Spherical equivalent refractive (SER) predictability
- Astigmatism accuracy
- Safety
See the details on percentage differences.
Any limitations?
Just a few, including that preop higher-order aberrations (HOAs) weren’t measured (so the change in HOAs caused by surgery couldn’t be determined).
Plus, a longer follow-up period may be able to “provide more insights” regarding the TENEO’s safety and efficacy, the study authors noted.
Finally, the conclusion.
The data demonstrated the safety and efficacy of using the TENEO during LASIK surgery for correcting myopia and myopic astigmatism, the authors concluded.
Even further, a patient-reported outcomes with LASIK (PROWL) questionnaire distributed to participants both preop and postop (at 9 months) indicated an “improved quality of vision in eyes with moderate to high myopia,” they stated.