Study of the Effectiveness and Safety of Ophtholic Ultra in Preventing and Correcting Ocular Surface Disturbances After Uncomplicated Cataract Surgery
This is a single-center, prospective, randomized, controlled, assessor-masked clinical study evaluating the effectiveness and safety of Ophtholic Ultra, a preservative-free moisturizing ophthalmic solution containing 0.2% tamarind seed polysaccharide and 0.4% sodium hyaluronate, in patients undergoing uncomplicated cataract surgery.
Cataract surgery can temporarily affect the ocular surface and tear film, leading to dry eye symptoms, discomfort, epithelial changes, and reduced tear film stability. This study will evaluate whether adding Ophtholic Ultra to standard postoperative treatment can improve ocular surface condition after cataract surgery.
Approximately 60 adults aged 50 to 70 years with age-related cataract will be randomized into three groups. One group will receive standard postoperative treatment plus Ophtholic Ultra for 3 months, the second group will receive standard postoperative treatment plus Ophtholic Ultra for 1 month, and the third group will receive standard postoperative treatment without moisturizing eye drops.
The primary outcome will be the change in tear film break-up time (TBUT) from baseline to Day 90 after cataract surgery. Secondary outcomes will include Schirmer I test results, corneal epithelial staining and defects, visual acuity, patient-reported ocular symptoms and comfort, refractive outcomes, adherence, tolerability, and adverse events.
Participants will be assessed before surgery and on Days 7, 30, and 90 after surgery.