Clinical trial NCT04702802: Clinical Study to Evaluate the Safety of the Viscoelastic Substance PRO-149 When Used During Phacoemulsification, Compared to Healon® EndoCoat.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-related Cataract
Phacoemulsification
Lead sponsor: Laboratorios Sophia S.A de C.V.
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 36
Sex: ALL
Minimum age (years): 49
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, controlled, open, comparative, randomized clinical trial.
Primary purpose: TREATMENT

Brief 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%).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in corneal endothelial cell count
timeFrame: Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)
measure: Change in intraocular Pressure (IOP)
timeFrame: Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit)
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 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)
measure: Change in central corneal thickness
timeFrame: Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)
measure: Change in anterior chamber cellularity
timeFrame: Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit)
measure: Change in anterior chamber flare
timeFrame: Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit)
measure: Change in Best Corrected Visual Acuity (BCVA)
timeFrame: Days: -15 (±2) (eligibility visit), 1 (first safety evaluation visit), 8 (±2) (second safety evaluation visit), and 29 (±2) (final visit)
Other outcomes:
measure: Trans-surgical evaluation
timeFrame: Days: 0 (surgery)
Locations:
city: Ciudad de mexico
country: Mexico
facility: SalaUno Salud, S.A.P.I. de C.V.
Study officials:
References:
citation: 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.