Early Patients-Reported Outcomes Symptoms And Satisfaction With Low Energy Dose Klex: The Prowk-Ss Study

The purpose of this study is to evaluate early patient-reported symptoms, satisfaction, and visual and refractive outcomes following low-energy dose KLEx in patients undergoing SmartSight lenticule extraction surgery for myopia and myopia with astigmatism. Outcomes are assessed using the Patient-Reported Outcomes for KLEx – Symptoms and Satisfaction (PROWK-SS) questionnaire. This modified PROWL-SS questionnaire measures patient satisfaction and visual symptoms, including glare, halos, starbursts, and double images.

This clinical study was conducted at the Muscat Eye Laser Center, a private ophthalmic surgery center in Muscat, Oman.

This prospective observational study included 114 patients (221 eyes) undergoing low-energy dose SmartSight lenticule extraction with the ATOS femtosecond laser (514 mJ/cm²), All surgeries were performed by a single surgeon, (JA). The PROWK-SS questionnaire was administered preoperatively and at one and three months postoperatively. Ms39 tomography, Peramis ocular aberrometry, Vision and refraction were evaluated preoperatively, one day postoperatively, and at three months. PROWK-SS scores range from 0 (worst) to 100 (best). Each symptom score was computed as the average of eight related questions, while satisfaction was assessed with a single question. Preoperative and postoperative scores were compared, with significance set at p < 0.05.

Mean pre-op PROWK-SS scores: 87 (Double Image), 81 (Glare), 73 (Halos), 63 (Starburst), 25 (Satisfaction). At one month, scores improved to 99, 95, 91, 95, and 93. All symptoms improved significantly (p < 0.05), Pre-op, 97% had scores <52 (dissatisfaction), while post-op, 100% had scores >52 (satisfaction), with 67% reporting complete satisfaction vs. 0% pre-op. At POD1, 100% of patients had UDVA ≥ pre-op CDVA, with 81% gaining ≥1 line. No patients lost CDVA, and 81% gained ≥1 line. Attempted vs. achieved SEQ followed Y = 0.9985X - 0.0014 (R² = 0.9981), with 100% within ±0.50D. Post-op, 100% had ≤0.50D astigmatism, 99% ≤0.25D. TIA vs. SIA followed Y = 0.9989X + 0.0025 (R² = 0.9966), and 99% had an astigmatism angle error between -5° and 5°.

Low-energy dose KLEx with SmartSight provided early and excellent efficacy, safety, and accuracy. All patients achieved UDVA ≥ pre-op CDVA, and no lines of CDVA were lost. The PROWK-SS showed significant symptom reduction, with 100% satisfaction scores, with 0% of patients reporting dissatisfaction postoperatively. These findings suggest KLEx provides early and excellent refractive results, with strong patient-reported outcomes, low symptom prevalence, and high satisfaction.