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

Laboratorios Sophia

Status: Completed

Conditions: Phacoemulsification; Age-related Cataract

Treatments: Device: Sodium hyaluronate 3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04702802

SOPH149-0220/I

Details and patient eligibility

About

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%).

Enrollment: 36 patients

Sex: All

Ages: 49+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 49 years old
• Age-related cataract diagnosis which requires phacoemulsification and monofocal intraocular lens implantation
• Being capable of voluntarily grant a signed informed consent.
• Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
• Willingness to be subjected to phacoemulsification and monofocal intraocular lens implantation.
• An anterior chamber depth of ≥ 2.8 mm measured through IOL Master®.
• Pre-surgical cardiologic evaluation that validates the patient's eligibility to surgical procedure, including supporting studies: blood biometry, blood chemistry, clotting time, and electrocardiogram. This evaluation must not exceed 45 days prior to the date of signing of the informed consent.

Exclusion criteria

• Previous history of any systemic medical affliction that prevents a patient from being considered eligible for the surgical procedure under sedation and topical anesthesia.
• Previous history of Diabetes Mellitus with A1C ≥ 6.5% (48 mmol/mol) or glucose levels (after no caloric ingestion for ≥ 8 hours) of ≥ 126 mg/dL (7.0 mmol/L).
• Poorly controlled systemic arterial hypertension, defined as a value ≥ 140/90 despite the use of three antihypertensive drugs (one of them a diuretic) at maximum dose.
• Previous history of ocular diseases that may limit the BCVA, or that may reactivate or worsen due to the surgical procedure or due to the use of topical steroids (por example, retinal detachment, macular degeneration, degenerative myopia, proliferative diabetic retinopathy, diabetic macular edema, optic neuritis, uveitis or any other kind of ocular inflammation, glaucoma, intraocular hypertension, corneal dystrophies or ectasias, history of ocular herpes or zoster).
• Active ocular infection
• Pseudoexfoliation syndrome in the eye to withstand surgery, or any other such zonular compromise.
• Pharmacological mydriasis < 6 mm.
• Any congenital anomalies in the eye to withstand surgery.
• Any alteration that prevents a reliable Goldmann tonometry in the eye to withstand surgery.
• IOP >21mmHg in the eye to withstand surgery, or previous history of IOP > 21 mmHg after topical steroid use.
• Corneal endothelial cell count < 1500 cells/mm2 in the eye to withstand surgery.
• Previous history of corneal or intraocular surgery.
• Planned multiple procedures during cataract surgery (for example, trabeculectomy, keratotomies, etc)
• Previous history of ocular trauma in the eye to withstand surgery (including surgical procedures)
• Having one functional eye.
• Having participated in clinical trials within 30 days prior to signing this study's informed consent form.
• Having participated previously in this study.
• Previous history of drug addiction within the last 2 years prior to signing this study's informed consent form.
• Having a previous history of any ophthalmological surgical procedure, within the last 3 months prior to the informed consent signing date.
• Having any kind of programed surgery during the period of this study.
• Being or having any immediate family members (spouse, parent/legal tutor, sibling or child) who work either in the investigation center or for the sponsor of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Arm 1; PRO-149

Experimental group

Description:

Viscoelastic substance PRO-149 (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.

Treatment:

Device: Sodium hyaluronate 3%

Device: Sodium hyaluronate 3%

Arm 2; Healon® EndoCoat

Active Comparator group

Description:

Viscoelastic substance Healon® EndoCoat (sodium hyaluronate 3%) in pre-filled syringe to be applied in the ocular anterior chamber during phacoemulsification surgery in an amount sufficient to form the desired intraocular space and allow the technical maneuvers required for the procedure.

Treatment:

Device: Sodium hyaluronate 3%

Device: Sodium hyaluronate 3%