Comparative Evaluation of Visual Outcomes and Patient Satisfaction with Indian-Manufactured versus Imported Extended Depth-of-Focus Intraocular Lenses in Cataract Surgery: A Prospective Masked Clinical Study

Abstract: Purpose: To compare the visual, functional, and patient-reported outcomes between Indian-manufactured and imported non-diffractive extended depth-of-focus (EDOF) intraocular lenses (IOLs) following bilateral cataract surgery. Methods: This prospective, single-masked clinical study included 30 patients (60 eyes), divided into two groups: 15 patients (30 eyes) received Indian-manufactured EDOF IOLs, and 15 patients (30 eyes) received imported wavefront-shaping EDOF IOLs. All surgeries were performed by a single surgeon using standardized phacoemulsification and bilateral implantation protocols at Shree K. P. Sanghvi Eye Institute, Surat, India. Postoperative evaluations included uncorrected and best-corrected distance (UCDVA, BCVA), intermediate (UIVA), and near (UNVA) visual acuities; contrast sensitivity under photopic and mesopic conditions; binocular defocus curve; and patient satisfaction assessed via the validated Catquest-9SF questionnaire. Statistical and clinical equivalence were defined as intergroup differences ≤±0.10 LogMAR or ≤±0.10 log units, with significance set at p < 0.05. Results: Both groups demonstrated excellent and clinically equivalent visual outcomes at one month. Mean UCDVA was −0.02 ± 0.05 LogMAR for imported and 0.04 ± 0.06 LogMAR for Indian IOLs (p = 0.058), while UIVA and UNVA were 0.09 ± 0.07 vs. 0.11 ± 0.09 LogMAR and 0.18 ± 0.08 vs. 0.20 ± 0.10 LogMAR, respectively (p > 0.05). Binocular functional vision (≤0.20 LogMAR) was maintained across a defocus range of +0.50 D to −1.75 D (p = 0.18). Photopic contrast sensitivity was slightly higher in imported IOLs (1.71 ± 0.07 vs. 1.66 ± 0.09 log units, p = 0.048), though the difference was below clinical significance. Patient satisfaction (Catquest-9SF: 91.6 ± 6.1 vs. 90.2 ± 5.3, p = 0.42) and spectacle independence (83% vs. 80%) were comparable. No major complications or adverse events occurred. Conclusion: Indian-manufactured EDOF IOLs provided visual and functional performance equivalent to imported wavefront-shaping lenses, with all outcomes within predefined clinical equivalence limits. Given their approximately 70% lower cost (INR 10,000–15,000 vs. 45,000–60,000 per eye), these findings highlight the potential of indigenous EDOF technology to deliver affordable, high-quality refractive outcomes and expand access to premium cataract surgery in developing regions.