Age-related Cataract, Phacoemulsification
Conditions
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%).
Interventions
DEVICESodium 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.
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot, controlled, open, comparative, randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
49 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Intraocular Pressure (IOP) | 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]) | 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. |
| Change in Corneal Endothelial Cell Count | Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anterior Chamber Flare | 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]) | 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. |
| Change in Best Corrected Visual Acuity (BCVA) | 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]) | 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. |
| Number of Participants Presenting Adverse Events | From Day -15 (±2) (eligibility visit) through Day 29 (±2) (final visit) | 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. |
| Change in Central Corneal Thickness | Days: -15 (±2) (eligibility visit [EV]), and 29 (±2) (final visit [FV]) | By means of specular microscopy, corneal thickness will be evaluated, reported in μm. |
| Change in Anterior Chamber Cellularity | 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]) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trans-surgical Evaluation | Days: 0 (surgery) | 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). |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 18 |
| 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.
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. | 18 |
| 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.
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. | 18 |
| 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.
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. | 18 |
| Total | 72 |
Baseline characteristics
| Characteristic | Arm 1; PRO-149 | Arm 2; Healon® EndoCoat | Total |
|---|---|---|---|
| Age, Continuous | 67.11 years STANDARD_DEVIATION 10.8 | 72.50 years STANDARD_DEVIATION 8.8 | 69.89 years STANDARD_DEVIATION 15.39 |
| Corneal Endothelial Cell Count | 2584.39 cells/mm2 STANDARD_DEVIATION 385.5 | 2558.33 cells/mm2 STANDARD_DEVIATION 363.4 | 2571.36 cells/mm2 STANDARD_DEVIATION 369.45 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Mexico | 18 participants | 18 participants | 36 participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 1 / 18 | 2 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1; PRO-149 | Change in Corneal Endothelial Cell Count | -441.33 cells/mm2 | Standard Deviation 420.4 |
| Arm 2; Healon® EndoCoat | Change in Corneal Endothelial Cell Count | -482.3 cells/mm2 | Standard Deviation 487.7 |
Primary
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])
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1; PRO-149 | Change in Intraocular Pressure (IOP) | V1 IOP | 19.28 mmHg | Standard Deviation 7.1 |
| Arm 1; PRO-149 | Change in Intraocular Pressure (IOP) | EV IOP | 15.83 mmHg | Standard Deviation 2.4 |
| Arm 1; PRO-149 | Change in Intraocular Pressure (IOP) | V2 IOP | 15.78 mmHg | Standard Deviation 2.7 |
| Arm 1; PRO-149 | Change in Intraocular Pressure (IOP) | FV IOP | 15.22 mmHg | Standard Deviation 3 |
| Arm 2; Healon® EndoCoat | Change in Intraocular Pressure (IOP) | FV IOP | 14.94 mmHg | Standard Deviation 2.7 |
| Arm 2; Healon® EndoCoat | Change in Intraocular Pressure (IOP) | V2 IOP | 15.56 mmHg | Standard Deviation 3.1 |
| Arm 2; Healon® EndoCoat | Change in Intraocular Pressure (IOP) | EV IOP | 15.78 mmHg | Standard Deviation 2.2 |
| Arm 2; Healon® EndoCoat | Change in Intraocular Pressure (IOP) | V1 IOP | 16.50 mmHg | Standard Deviation 4.6 |
Secondary
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.
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])
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | EV Anterior chamber cellularity : 0 (none) | 18 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | EV Anterior chamber cellularity : 1/2 (1-5) | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | EV Anterior chamber cellularity : 1 + (6-15) | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | EV Anterior chamber cellularity : 2 + (16-25 | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | V1 Anterior chamber cellularity : 0 (none) | 1 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | V1 Anterior chamber cellularity : 1/2 (1-5) | 7 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | V1 Anterior chamber cellularity : 1 + (6-15) | 8 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | V1 Anterior chamber cellularity : 2 + (16-25 | 2 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | V2 Anterior chamber cellularity : 0 (none) | 9 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | V2 Anterior chamber cellularity : 1/2 (1-5) | 8 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | V2 Anterior chamber cellularity : 1 + (6-15) | 1 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | V2 Anterior chamber cellularity : 2 + (16-25 | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | FV Anterior chamber cellularity : 0 (none) | 18 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | FV Anterior chamber cellularity : 1/2 (1-5) | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | FV Anterior chamber cellularity : 1 + (6-15) | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Cellularity | FV Anterior chamber cellularity : 2 + (16-25 | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | FV Anterior chamber cellularity : 2 + (16-25 | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | EV Anterior chamber cellularity : 0 (none) | 18 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | V2 Anterior chamber cellularity : 0 (none) | 9 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | EV Anterior chamber cellularity : 1/2 (1-5) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | FV Anterior chamber cellularity : 0 (none) | 18 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | EV Anterior chamber cellularity : 1 + (6-15) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | V2 Anterior chamber cellularity : 1/2 (1-5) | 7 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | EV Anterior chamber cellularity : 2 + (16-25 | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | FV Anterior chamber cellularity : 1 + (6-15) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | V1 Anterior chamber cellularity : 0 (none) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | V2 Anterior chamber cellularity : 1 + (6-15) | 2 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | V1 Anterior chamber cellularity : 1/2 (1-5) | 5 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | FV Anterior chamber cellularity : 1/2 (1-5) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | V1 Anterior chamber cellularity : 1 + (6-15) | 9 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | V2 Anterior chamber cellularity : 2 + (16-25 | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Cellularity | V1 Anterior chamber cellularity : 2 + (16-25 | 4 Cases (eyes) |
Secondary
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])
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | EV Anterior Chamber Flare : 0 (No flare) | 18 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | EV Anterior Chamber Flare : 1+ (Mild) | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | EV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | V1 Anterior Chamber Flare : 0 (No flare) | 11 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | V1 Anterior Chamber Flare : 1+ (Mild) | 6 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | V1 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) | 1 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | V2 Anterior Chamber Flare : 0 (No flare) | 18 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | V2 Anterior Chamber Flare : 1+ (Mild) | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | V2 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | FV Anterior Chamber Flare : 0 (No flare) | 18 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | FV Anterior Chamber Flare : 1+ (Mild) | 0 Cases (eyes) |
| Arm 1; PRO-149 | Change in Anterior Chamber Flare | FV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | FV Anterior Chamber Flare : 1+ (Mild) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | EV Anterior Chamber Flare : 0 (No flare) | 18 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | V2 Anterior Chamber Flare : 0 (No flare) | 17 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | EV Anterior Chamber Flare : 1+ (Mild) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | FV Anterior Chamber Flare : 0 (No flare) | 18 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | EV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | V2 Anterior Chamber Flare : 1+ (Mild) | 1 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | V1 Anterior Chamber Flare : 0 (No flare) | 6 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | FV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | V1 Anterior Chamber Flare : 1+ (Mild) | 11 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | V2 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) | 0 Cases (eyes) |
| Arm 2; Healon® EndoCoat | Change in Anterior Chamber Flare | V1 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) | 1 Cases (eyes) |
Secondary
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])
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1; PRO-149 | Change in Best Corrected Visual Acuity (BCVA) | EV BCVA | 0.33 decimal score (Snellen Chart) | Standard Deviation 0.19 |
| Arm 1; PRO-149 | Change in Best Corrected Visual Acuity (BCVA) | V1 BCVA | 0.49 decimal score (Snellen Chart) | Standard Deviation 0.21 |
| Arm 1; PRO-149 | Change in Best Corrected Visual Acuity (BCVA) | V2 BCVA | 0.81 decimal score (Snellen Chart) | Standard Deviation 0.21 |
| Arm 1; PRO-149 | Change in Best Corrected Visual Acuity (BCVA) | FV BCVA | 0.93 decimal score (Snellen Chart) | Standard Deviation 0.14 |
| Arm 2; Healon® EndoCoat | Change in Best Corrected Visual Acuity (BCVA) | FV BCVA | 0.91 decimal score (Snellen Chart) | Standard Deviation 0.13 |
| Arm 2; Healon® EndoCoat | Change in Best Corrected Visual Acuity (BCVA) | EV BCVA | 0.42 decimal score (Snellen Chart) | Standard Deviation 0.17 |
| Arm 2; Healon® EndoCoat | Change in Best Corrected Visual Acuity (BCVA) | V2 BCVA | 0.80 decimal score (Snellen Chart) | Standard Deviation 0.16 |
| Arm 2; Healon® EndoCoat | Change in Best Corrected Visual Acuity (BCVA) | V1 BCVA | 0.56 decimal score (Snellen Chart) | Standard Deviation 0.24 |
Secondary
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])
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1; PRO-149 | Change in Central Corneal Thickness | EV Central Corneal Thickness | 517.61 μm | Standard Deviation 34.8 |
| Arm 1; PRO-149 | Change in Central Corneal Thickness | FV Central Corneal Thickness | 527.50 μm | Standard Deviation 44.4 |
| Arm 2; Healon® EndoCoat | Change in Central Corneal Thickness | EV Central Corneal Thickness | 525.17 μm | Standard Deviation 31.5 |
| Arm 2; Healon® EndoCoat | Change in Central Corneal Thickness | FV Central Corneal Thickness | 527.94 μm | Standard Deviation 27.6 |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1; PRO-149 | Number of Participants Presenting Adverse Events | 1 Participants |
| Arm 2; Healon® EndoCoat | Number of Participants Presenting Adverse Events | 2 Participants |
Other Pre-specified
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).
Time frame: Days: 0 (surgery)
Population: (the average performance score across devices)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1; PRO-149 | Trans-surgical Evaluation | 3.47 score on a scale | Standard Deviation 0.6 |
| Arm 2; Healon® EndoCoat | Trans-surgical Evaluation | 3.50 score on a scale | Standard Deviation 0.6 |