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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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1; PRO-149 | Experimental | 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. |
|
| Arm 2; Healon® EndoCoat | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium hyaluronate 3% | Device | 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. |
| 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 [EV]), 1 (first safety evaluation visit [V1]), 8 (±2) (second safety evaluation visit [V2]), and 29 (±2) (final visit [FV]) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Day -15 (±2) (eligibility visit) through Day 29 (±2) (final visit) |
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oscar Olvera Montaño, MD | Regional Medical Affairs Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SalaUno Salud, S.A.P.I. de C.V. | Mexico City | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36046598 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | cells/mm2 | Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit) | Cases (eyes) | Cases (eyes) |
|
From day 1 (basal visit) to the final visit on day 29 (±2 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| conjunctival hyperemia | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandra Sanchez-Ríos M.D. | Laboratorios Sophia | :+52 (33) 3001 4200 | alejandra.sanchez@sophia.com.mx |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2020 | Dec 15, 2025 | Prot_SAP_000.pdf |
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Pilot, controlled, open, comparative, randomized clinical trial.
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|
| Sodium hyaluronate 3% | Device | 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. |
|
|
| Change in Central Corneal Thickness | By means of specular microscopy, corneal thickness will be evaluated, reported in μm. | 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. | 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. | 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. | 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]) |
| Days: 0 (surgery) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Cases (Eyes) |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Corneal Endothelial Cell Count | By means of specular microscopy, endothelial cell was performed. Density expressed in cells/mm2 will was recorded. Normal density varies according to age, but an average of 1500 - 3500 cells/mm2 (age 40 to 90) has been described. | Mean | Standard Deviation | cells/mm2 | Cases (Eyes) |
|
|
| OG001 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | 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]) | Cases (eyes) | Cases (eyes) |
|
|
|
| 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. | Posted | Count of Participants | Participants | From Day -15 (±2) (eligibility visit) through Day 29 (±2) (final visit) |
|
|
|
| Secondary | Change in Central Corneal Thickness | By means of specular microscopy, corneal thickness will be evaluated, reported in μm. | Posted | Mean | Standard Deviation | μm | Days: -15 (±2) (eligibility visit [EV]), and 29 (±2) (final visit [FV]) | Cases (eyes) | Cases (eyes) |
|
|
|
| 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. | Posted | Number | Cases (eyes) | 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]) | Cases (eyes) | 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. | Posted | Number | Cases (eyes) | 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]) | Cases (eyes) | 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. | Posted | Mean | Standard Deviation | decimal score (Snellen Chart) | 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]) | Cases (eyes) | Cases (eyes) |
|
|
|
| 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). | (the average performance score across devices) | Posted | Mean | Standard Deviation | score on a scale | Days: 0 (surgery) |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 2 | 18 |
| intraocular hypertension | Eye disorders | Systematic Assessment |
|
| rupture of the posterior capsule | Eye disorders | Systematic Assessment |
|
| striations in the descemet membran | Eye disorders | Systematic Assessment |
|
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| V2 IOP |
|
| FV IOP |
|
| EV Anterior chamber cellularity : 1 + (6-15) |
|
| EV Anterior chamber cellularity : 2 + (16-25 |
|
| V1 Anterior chamber cellularity : 0 (none) |
|
| V1 Anterior chamber cellularity : 1/2 (1-5) |
|
| V1 Anterior chamber cellularity : 1 + (6-15) |
|
| V1 Anterior chamber cellularity : 2 + (16-25 |
|
| V2 Anterior chamber cellularity : 0 (none) |
|
| V2 Anterior chamber cellularity : 1/2 (1-5) |
|
| V2 Anterior chamber cellularity : 1 + (6-15) |
|
| V2 Anterior chamber cellularity : 2 + (16-25 |
|
| FV Anterior chamber cellularity : 0 (none) |
|
| FV Anterior chamber cellularity : 1/2 (1-5) |
|
| FV Anterior chamber cellularity : 1 + (6-15) |
|
| FV Anterior chamber cellularity : 2 + (16-25 |
|
| EV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) |
|
| V1 Anterior Chamber Flare : 0 (No flare) |
|
| V1 Anterior Chamber Flare : 1+ (Mild) |
|
| V1 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) |
|
| V2 Anterior Chamber Flare : 0 (No flare) |
|
| V2 Anterior Chamber Flare : 1+ (Mild) |
|
| V2 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) |
|
| FV Anterior Chamber Flare : 0 (No flare) |
|
| FV Anterior Chamber Flare : 1+ (Mild) |
|
| FV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible) |
|
| V2 BCVA |
|
| FV BCVA |
|