Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used During Phacoemulsification, Compared to Healon® EndoCoat.

Study Overview
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Brief Summary
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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%).

Official Title
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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.

Conditions
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Age-related Cataract, Phacoemulsification

Intervention / Treatment
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* Device: Sodium hyaluronate 3%
* Device: Sodium hyaluronate 3%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot, controlled, open, comparative, randomized clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1; PRO-149<br>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. | Device: Sodium hyaluronate 3%<br>* 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.<br>* Other names: PRO-149;|
| Active Comparator: Arm 2; Healon® EndoCoat<br>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. | Device: Sodium hyaluronate 3%<br>* 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.<br>* Other names: Healon® EndoCoat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in corneal endothelial cell count | By means of specular microscopy, endothelial cell count will take place. Density expressed in cells/mm2 will be recorded. Normal density varies according to age, but an average of 1500 - 3500 cells/mm2 (age 40 to 90) has been described. | Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit) | 
| Change in intraocular Pressure (IOP) | Measured through Goldman tonometer in milligrams of mercury (mmHg). After instillation of topical anesthetic (tetracaine 0.5%) and fluorescein stain, IOP is evaluated twice to obtain an average to be recorded. Normal values are considered between 10 and 21 mmHg. | Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Presence/absence adverse events, defined as the appearance of any unfavorable reaction in a patient participating in a clinical investigation in which any pharmaceutical product is being administered, regardless of the causal attribution. | Days: -15 (±2) (eligibility visit), -8 (±3) (surgery scheduling visit), 0 (surgery), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit) | 
| Change in central corneal thickness | By means of specular microscopy, corneal thickness will be evaluated. | Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit) | 
| Change in anterior chamber cellularity | During evaluation with a slit lamp, setting the beam of light to 0.2 mm x 0.2 mm dimensions, it will be obliquely aimed to the anterior chamber. The standardized scale for anterior chamber cellularity (uveitis) will be used, according to number of observed cells: 0 (none), ½+ (1-5), 1+ (6-15), 2+ (16-25), 3+ (26-60), 4+ (>60). | Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit) | 
| Change in anterior chamber flare | During evaluation with a slit lamp, setting the beam of light to 0.2 mm x 0.2 mm dimensions, it will be obliquely aimed to the anterior chamber. The standardized scale for anterior chamber cellularity (uveitis) will be used: 0 (No flare), 1+ (Mild), 2+ (Moderate; iris and lens clearly visible), 3+ (Marked; slightly blurry iris and lens), 4+ (>60 cells; fibrin) | Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit) | 
| Change in Best Corrected Visual Acuity (BCVA) | With the patient's best possible refractive correction, visual acuity will be evaluated through the Snellen chart. Its notation (fraction or decimal) is described as the distance from the chart at which the test is performed, divided by the distance at which a letter equals vertically 5 minutes of arc. | Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit) |