NCT04702802

Study to Evaluate the Safety of the Viscoelastic Substance PRO-149, Compared to Healon® EndoCoat.

Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used as a Device During Phacoemulsification and Intraocular Lens Implantation in Patients With Age-related Cataract, Compared to Healon® EndoCoat.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 49 Years
• Healthy volunteers: Not accepted

Summary

Pilot, controlled, parallel group, open, randomized clinical trial to evaluate the safety of the viscoelastic substance PRO-149 (sodium hyaluronate 3%) after trans-surgical administration as a device in performing phacoemulsification and intraocular lens implantation in 36 patients with age-related cataract, compared to Healon® EndoCoat (sodium hyaluronate 3%).

Conditions

• Age-related Cataract
• Phacoemulsification

Interventions

Type	Name	Description
DEVICE	Sodium hyaluronate 3%	During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.
DEVICE	Sodium hyaluronate 3%	During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.

Timeline

• Start date: 2021-09-07
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2021-01-11
• Last updated: 2025-12-16
• Results posted: 2025-12-16

Locations

1 site across 1 country: Mexico