Comparing Surgical Outcomes of Sodium Hyaluronate Versus Hypromellose as Ophthalmic Viscosurgical Devices in Topical Phacoemulsification Among Diabetic Patients with Cataract: A Prospective Comparative Interventional Cohort Study Protocol (Preprint)

BACKGROUND : Diabetic patients undergoing cataract surgery face heightened risks due to compromised corneal endothelium, impaired healing, and poor pupillary dilatation. The choice of ophthalmic viscosurgical device (OVD) during phacoemulsification may significantly affect surgical outcomes in this vulnerable population; however, comparative evidence remains limited. OBJECTIVE This study aims to compare surgical outcomes of sodium hyaluronate ophthalmic solution (Hyloject) versus hypromellose ophthalmic solution USP (Hyprosol) as OVDs in topical phacoemulsification among diabetic patients with cataract at a tertiary care centre in central India. METHODS This is a prospective comparative non-randomised interventional study to be conducted at the Department of Ophthalmology, Acharya Vinoba Bhave Rural Hospital, Sawangi, Wardha, Maharashtra, India. A total of 174 diabetic patients (87 per group) aged above 40 years with senile cataract undergoing phacoemulsification will be enrolled using alternate sequential allocation. The primary outcome is change in corneal endothelial cell density assessed by specular microscopy; secondary outcomes include visual acuity recovery, intraocular pressure changes, and postoperative complications, all assessed preoperatively and at day 1, day 15, and 1 month postoperatively. RESULTS The study protocol was approved by the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (Deemed to be University) on July 9, 2025 (Ref. No. DMIHER(DU)/IEC/2025/370), with a subsequent amendment approved on February 21, 2026 (Ref. No. DMIHER(DU)/IEC/2026/018). The study was registered with the Clinical Trials Registry India on October 15, 2025 (CTRI/2025/10/096085). Enrollment commenced in November 2025; as of March 5, 2026, 35 participants have been enrolled, with 13 allocated to Group 1 (sodium hyaluronate) and 12 to Group 2 (hypromellose); the remaining participants are awaiting surgery and postoperative follow-up. Data collection is projected to be completed by August 2027, with final results expected to be submitted for publication by October 2027. CONCLUSIONS This study is expected to provide comparative evidence on the safety and efficacy of two commonly used OVDs in diabetic cataract surgery, informing evidence-based selection of viscoelastic agents to optimise outcomes in this high-risk population. Identifying the optimal OVD for endothelial protection in diabetic eyes may carry significant clinical relevance in regions such as India, where the dual burden of diabetes and cataract is substantial and cataract surgery volumes are high. CLINICALTRIAL Clinical Trials Registry of India (CTRI): CTRI/2025/10/096085. Registered October 15, 2025.