Trial Outcomes & Findings for Study to Evaluate the Safety of the Viscoelastic Substance PRO-149, Compared to Healon® EndoCoat. (NCT NCT04702802)
NCT ID: NCT04702802
Last Updated: 2025-12-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Days: -15 (±2) (eligibility visit), and 29 (±2) (final visit)
Results posted on
2025-12-16
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm 1; PRO-149
n=18 Cases (Eyes)
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.
|
Arm 2; Healon® EndoCoat
n=18 Cases (Eyes)
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.
|
Total
n=36 Cases (Eyes)
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.11 years
STANDARD_DEVIATION 10.8 • n=18 Participants
|
72.50 years
STANDARD_DEVIATION 8.8 • n=18 Participants
|
69.89 years
STANDARD_DEVIATION 15.39 • n=36 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=18 Participants
|
13 Participants
n=18 Participants
|
24 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
12 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Mexico
|
18 participants
n=18 Participants
|
18 participants
n=18 Participants
|
36 participants
n=36 Participants
|
|
Corneal Endothelial Cell Count
|
2584.39 cells/mm2
STANDARD_DEVIATION 385.5 • n=18 Cases (Eyes)
|
2558.33 cells/mm2
STANDARD_DEVIATION 363.4 • n=18 Cases (Eyes)
|
2571.36 cells/mm2
STANDARD_DEVIATION 369.45 • n=36 Cases (Eyes)
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1; PRO-149
n=18 Cases (eyes)
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.
|
Arm 2; Healon® EndoCoat
n=18 Cases (eyes)
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.
|
|---|---|---|
|
Change in Corneal Endothelial Cell Count
|
-441.33 cells/mm2
Standard Deviation 420.4
|
-482.3 cells/mm2
Standard Deviation 487.7
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1; PRO-149
n=18 Cases (eyes)
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.
|
Arm 2; Healon® EndoCoat
n=18 Cases (eyes)
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.
|
|---|---|---|
|
Change in Intraocular Pressure (IOP)
EV IOP
|
15.83 mmHg
Standard Deviation 2.4
|
15.78 mmHg
Standard Deviation 2.2
|
|
Change in Intraocular Pressure (IOP)
V2 IOP
|
15.78 mmHg
Standard Deviation 2.7
|
15.56 mmHg
Standard Deviation 3.1
|
|
Change in Intraocular Pressure (IOP)
FV IOP
|
15.22 mmHg
Standard Deviation 3.0
|
14.94 mmHg
Standard Deviation 2.7
|
|
Change in Intraocular Pressure (IOP)
V1 IOP
|
19.28 mmHg
Standard Deviation 7.1
|
16.50 mmHg
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1; PRO-149
n=18 Participants
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.
|
Arm 2; Healon® EndoCoat
n=18 Participants
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.
|
|---|---|---|
|
Number of Participants Presenting Adverse Events
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1; PRO-149
n=18 Cases (eyes)
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.
|
Arm 2; Healon® EndoCoat
n=18 Cases (eyes)
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.
|
|---|---|---|
|
Change in Central Corneal Thickness
EV Central Corneal Thickness
|
517.61 μm
Standard Deviation 34.8
|
525.17 μm
Standard Deviation 31.5
|
|
Change in Central Corneal Thickness
FV Central Corneal Thickness
|
527.50 μm
Standard Deviation 44.4
|
527.94 μm
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1; PRO-149
n=18 Cases (eyes)
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.
|
Arm 2; Healon® EndoCoat
n=18 Cases (eyes)
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.
|
|---|---|---|
|
Change in Anterior Chamber Cellularity
EV Anterior chamber cellularity : 2 + (16-25
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
V1 Anterior chamber cellularity : 0 (none)
|
1 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
V1 Anterior chamber cellularity : 1/2 (1-5)
|
7 Cases (eyes)
|
5 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
V1 Anterior chamber cellularity : 1 + (6-15)
|
8 Cases (eyes)
|
9 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
V2 Anterior chamber cellularity : 0 (none)
|
9 Cases (eyes)
|
9 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
V2 Anterior chamber cellularity : 2 + (16-25
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
FV Anterior chamber cellularity : 0 (none)
|
18 Cases (eyes)
|
18 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
EV Anterior chamber cellularity : 0 (none)
|
18 Cases (eyes)
|
18 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
EV Anterior chamber cellularity : 1/2 (1-5)
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
EV Anterior chamber cellularity : 1 + (6-15)
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
V1 Anterior chamber cellularity : 2 + (16-25
|
2 Cases (eyes)
|
4 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
V2 Anterior chamber cellularity : 1/2 (1-5)
|
8 Cases (eyes)
|
7 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
V2 Anterior chamber cellularity : 1 + (6-15)
|
1 Cases (eyes)
|
2 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
FV Anterior chamber cellularity : 1/2 (1-5)
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
FV Anterior chamber cellularity : 1 + (6-15)
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Cellularity
FV Anterior chamber cellularity : 2 + (16-25
|
0 Cases (eyes)
|
0 Cases (eyes)
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1; PRO-149
n=18 Cases (eyes)
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.
|
Arm 2; Healon® EndoCoat
n=18 Cases (eyes)
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.
|
|---|---|---|
|
Change in Anterior Chamber Flare
EV Anterior Chamber Flare : 1+ (Mild)
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Flare
V1 Anterior Chamber Flare : 1+ (Mild)
|
6 Cases (eyes)
|
11 Cases (eyes)
|
|
Change in Anterior Chamber Flare
V1 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible)
|
1 Cases (eyes)
|
1 Cases (eyes)
|
|
Change in Anterior Chamber Flare
V2 Anterior Chamber Flare : 0 (No flare)
|
18 Cases (eyes)
|
17 Cases (eyes)
|
|
Change in Anterior Chamber Flare
V2 Anterior Chamber Flare : 1+ (Mild)
|
0 Cases (eyes)
|
1 Cases (eyes)
|
|
Change in Anterior Chamber Flare
EV Anterior Chamber Flare : 0 (No flare)
|
18 Cases (eyes)
|
18 Cases (eyes)
|
|
Change in Anterior Chamber Flare
EV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible)
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Flare
V1 Anterior Chamber Flare : 0 (No flare)
|
11 Cases (eyes)
|
6 Cases (eyes)
|
|
Change in Anterior Chamber Flare
V2 Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible)
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Flare
FV Anterior Chamber Flare : 0 (No flare)
|
18 Cases (eyes)
|
18 Cases (eyes)
|
|
Change in Anterior Chamber Flare
FV Anterior Chamber Flare : 1+ (Mild)
|
0 Cases (eyes)
|
0 Cases (eyes)
|
|
Change in Anterior Chamber Flare
FV Anterior Chamber Flare : 2+ (Moderate; iris and lens clearly visible)
|
0 Cases (eyes)
|
0 Cases (eyes)
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1; PRO-149
n=18 Cases (eyes)
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.
|
Arm 2; Healon® EndoCoat
n=18 Cases (eyes)
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.
|
|---|---|---|
|
Change in Best Corrected Visual Acuity (BCVA)
EV BCVA
|
0.33 decimal score (Snellen Chart)
Standard Deviation 0.19
|
0.42 decimal score (Snellen Chart)
Standard Deviation 0.17
|
|
Change in Best Corrected Visual Acuity (BCVA)
V1 BCVA
|
0.49 decimal score (Snellen Chart)
Standard Deviation 0.21
|
0.56 decimal score (Snellen Chart)
Standard Deviation 0.24
|
|
Change in Best Corrected Visual Acuity (BCVA)
V2 BCVA
|
0.81 decimal score (Snellen Chart)
Standard Deviation 0.21
|
0.80 decimal score (Snellen Chart)
Standard Deviation 0.16
|
|
Change in Best Corrected Visual Acuity (BCVA)
FV BCVA
|
0.93 decimal score (Snellen Chart)
Standard Deviation 0.14
|
0.91 decimal score (Snellen Chart)
Standard Deviation 0.13
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days: 0 (surgery)Population: (the average performance score across devices)
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).
Outcome measures
| Measure |
Arm 1; PRO-149
n=18 Participants
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.
|
Arm 2; Healon® EndoCoat
n=18 Participants
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.
|
|---|---|---|
|
Trans-surgical Evaluation
|
3.47 score on a scale
Standard Deviation 0.6
|
3.50 score on a scale
Standard Deviation 0.6
|
Adverse Events
Arm 1; PRO-149
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 2; Healon® EndoCoat
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1; PRO-149
n=18 participants at risk
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.
|
Arm 2; Healon® EndoCoat
n=18 participants at risk
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.
|
|---|---|---|
|
Eye disorders
conjunctival hyperemia
|
0.00%
0/18 • From day 1 (basal visit) to the final visit on day 29 (±2 days)
|
5.6%
1/18 • From day 1 (basal visit) to the final visit on day 29 (±2 days)
|
|
Eye disorders
intraocular hypertension
|
5.6%
1/18 • From day 1 (basal visit) to the final visit on day 29 (±2 days)
|
0.00%
0/18 • From day 1 (basal visit) to the final visit on day 29 (±2 days)
|
|
Eye disorders
rupture of the posterior capsule
|
5.6%
1/18 • From day 1 (basal visit) to the final visit on day 29 (±2 days)
|
0.00%
0/18 • From day 1 (basal visit) to the final visit on day 29 (±2 days)
|
|
Eye disorders
striations in the descemet membran
|
0.00%
0/18 • From day 1 (basal visit) to the final visit on day 29 (±2 days)
|
5.6%
1/18 • From day 1 (basal visit) to the final visit on day 29 (±2 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place