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

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.

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%).

Study Overview

• Status: Completed
• Conditions: Age-related Cataract; Phacoemulsification
• Intervention / Treatment: Device: Sodium hyaluronate 3%

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Ciudad de mexico, Mexico
    • SalaUno Salud, S.A.P.I. de C.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; PRO-149; 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%; 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.; Other Names: Healon® EndoCoat
Active Comparator: Arm 2; Healon® EndoCoat; 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%; 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.; Other Names: Healon® EndoCoat

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trans-surgical evaluation	During the phacoemulsification and intraocular lens implantation, the surgeon will evaluate the performance of the viscoelastic substance used during the procedure trough a questionnaire that will inquire on the following: Capability to maintain a formed anterior chamber during continuous circular capsulorhexis and intraocular lens implantation, retention during phacoemulsification, user-friendliness, ergonomics, ease of use during capsulorhexis, transparency during surgery and ease of use during extraction. Scale: 0 (very bad), 1 (bad), 2 (acceptable), 3 (good), 4 (very good).	Days: 0 (surgery)

Collaborators and Investigators

• Sponsor: Laboratorios Sophia S.A de C.V.

Publications and helpful links

General Publications

• Palacio-Pastrana C, Munoz-Villegas P, Daniel-Dorantes F, Sanchez-Rios A, Olvera-Montano O, Martinez-Montoya YI, Quintana-Hau JD, Baiza-Duran LM. Evaluation of the Rheological Properties, Preclinical Safety, and Clinical Effectiveness of a New Dispersive Ophthalmic Viscoelastic Device for Cataract Surgery. Med Devices (Auckl). 2022 Aug 24;15:293-305. doi: 10.2147/MDER.S379050. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Actual): October 29, 2021
• Study Completion (Actual): October 29, 2021

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: SOPH149-0220/I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No