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ACTIVE NOT RECRUITING

NCT07868965

PHASE4

Evaluation of Ophtholic Ultra for Ocular Surface Protection After Cataract Surgery

Sponsor: Kazakh Eye Research Institute

View on ClinicalTrials.gov

Summary

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.

Official title: A Single-Center, Prospective, Randomized, Controlled, Assessor-Blinded Study Evaluating the Efficacy and Safety of Ophtholic Ultra Ophthalmic Lubricating Solution for the Prevention and Correction of Ocular Surface Disorders After Uncomplicated Cataract Surgery

Key Details

Gender

All

Age Range

50 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-24

Completion Date

2026-11-24

Last Updated

2026-10-09

Healthy Volunteers

Conditions

Dry Eye Disease (DED)

Interventions

DRUG

Ophtholic Ultra

Preservative-free multidose ophthalmic lubricating solution containing 0.2% tamarind seed polysaccharide (TS-polysaccharide) and 0.4% sodium hyaluronate. One drop is instilled into the operated eye four times daily from Day -1 through Day 90, in addition to standard postoperative therapy.

DRUG

Ophtholic Ultra

OTHER

Standard postoperative therapy without lubricating eye drops

Standard postoperative therapy after uncomplicated phacoemulsification with intraocular lens implantation, without the use of lubricating ophthalmic drops.

Inclusion Criteria 1\. Age 50 to 70 years, inclusive. 2. Age-related cataract with a clinical indication for planned phacoemulsification with intraocular lens implantation. 3. Ability to understand the study information and provide written informed consent. 4. Willingness and ability to comply with the scheduled study visits and study procedures. 5. Ocular surface symptoms, including burning, dryness, tearing, frequent blinking, or foreign body sensation. 6. Corneal transparency sufficient to perform tear film break-up time assessment and fluorescein staining. 7. Uncomplicated cataract surgery completed without complications requiring a change in standard postoperative management. Exclusion Criteria 1\. Active infectious or clinically significant inflammatory disease of the ocular surface, eyelids, or lacrimal system. 2. Severe dry eye disease requiring continuous anti-inflammatory, immunomodulatory, or intensive tear replacement therapy. 3. Sjögren syndrome, active systemic autoimmune disease, or another condition expected to substantially affect tear production. 4. Corneal scar, dystrophy, degeneration, marked irregularity, or neurotrophic keratopathy. 5. Significant meibomian gland dysfunction requiring immediate specialized treatment. 6. Uveitis, uncontrolled glaucoma, or previous corneal refractive or other corneal surgery within 12 months before enrollment. 7. Contact lens use within 14 days before the baseline assessment. 8. Use of artificial tears or other topical ophthalmic products affecting the ocular surface that cannot be discontinued for at least 24 hours before baseline testing. 9. Known allergy or hypersensitivity to any component of Ophtholic® Ultra or fluorescein. 10. Any serious medical or cognitive condition that, in the investigator's opinion, makes participation unsafe or prevents reliable study data collection. Exclusion Criteria Before Randomization 1\. Intraoperative posterior capsule rupture, significant vitreous loss, inability to implant the planned intraocular lens, or another significant intraoperative complication. 2. Need for additional surgical intervention or a change in the standard postoperative eye drop regimen that substantially differs from the study protocol. 3. Withdrawal of informed consent before randomization.

Locations (1)

Kazakh Eye Research Institute

Almaty, Kazakhstan