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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
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.
SalaUno Salud, S.A.P.I. de C.V.
Mexico City, Mexico
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.
Time frame: 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.
Time frame: Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])
Number of Participants Presenting 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.
Time frame: From Day -15 (±2) (eligibility visit) through Day 29 (±2) (final visit)
Change in Central Corneal Thickness
By means of specular microscopy, corneal thickness will be evaluated, reported in μm.
Time frame: Days: -15 (±2) (eligibility visit [EV]), and 29 (±2) (final visit [FV])
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 Standardization of Uveitis Nomenclature (SUN) system was used for grading this variable, according to number of observed cells: grade 0 (none), grade ½+ (1-5 cells), grade 1+ (6-15 cells), grade 2+ (16-25 cells), grade 3+ (26-60 cells), grade 4+ (\>60 cells). A higher score represents a worse outcome.
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Time frame: Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])
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 Standardization of Uveitis Nomenclature (SUN) system was used for grading this variable: grade 0 (No flare), grade 1+ (Mild), grade 2+ (Moderate; iris and lens clearly visible), grade 3+ (Marked; slightly blurry iris and lens), grade 4+ (\>60 cells; fibrin). A higher score represents a worse outcome.
Time frame: Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])
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.
Time frame: Days: -15 (±2) (eligibility visit [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV])