Ocular Hypertension, Posterior Capsule Opacification
Conditions
Keywords
Nd-YAG capsulotomy, ocular hypertension, brimonidine, brinzolamide
Brief summary
To compare the efficacy of a Brinzolamide/Brimonidine fixed combination (FC) with Brimonidine 0.2% in preventing intraocular pressure (IOP) elevations after neodymium: yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy.
Detailed description
In this prospective, randomized, double masked clinical trial, patients scheduled to undergo Nd:YAG laser posterior capsulotomy for posterior capsule opacification are randomized in 3 groups. The Brimonidine group receives 1 drop of Brimonidine 0.2%. The Brinzolamide/Brimonidine group receives 1 drop of Brinzolamide 1%/Brimonidine 0.2% fixed combination. The Control group receives artificial tears. All groups are administered a single drop instillation, approximately one hour before Nd:YAG application. Intraocular pressure measurements are performed before treatment (baseline) and at the 1, 3, 24 hours and 1 week post treatment. Dexamethasone ophthalmic drops are prescribed q.i.d. for one week after the procedure.
Interventions
DRUGBrinzolamide/Brimonidine FC
1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
DRUGBrimonidine 0.2%
1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
DRUGArtificial tears
1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Sponsors
University Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients are masked to their assignment by covering the labels on the bottles of the drugs administered The investigator responsible for the measurement of the intraocular pressure is also masked to the intervention administered to each patient.
Intervention model description
This is a prospective, randomized, double masked comparative study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* patients scheduled to undergo laser posterior capsulotomy due to posterior capsule opacification (PCO) after uneventful phacoemulsification cataract extraction with implantation of posterior chamber intraocular lenses (IOL/PC).
Exclusion criteria
* baseline IOP greater than 21mmHg * glaucomatous eyes, already under treatment with anti glaucomatic medications * intraocular surgery except for uncomplicated cataract surgery * previous photorefractive surgery * active ocular inflammation or infection * patients under systemic administration of medications known to affect IOP * patients with severe respiratory or cardiovascular disease * pregnant or breast feeding women, and individuals with known hypersensitivity or contraindication for administration of the medications tested * a measurement of IOP \> 30 mmHg at any time point of the study, or an increase from baseline \>20 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy | 1 hour | Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP |
| Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy | 3 hours | Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP |
| Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy | 24 hours | Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP |
| Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy | 1 week | Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brinzolamide/Brimonidine FC 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy | 27 |
| Brimonidine 0.2% 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy | 27 |
| Artificial Tears 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy | 25 |
| Total | 79 |
Baseline characteristics
| Characteristic | Brinzolamide/Brimonidine FC | Total | Artificial Tears | Brimonidine 0.2% |
|---|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 6.3 | 65.5 years STANDARD_DEVIATION 5.8 | 67.6 years STANDARD_DEVIATION 3.9 | 65.2 years STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 79 Participants | 25 Participants | 27 Participants |
| Region of Enrollment Greece | 27 participants | 79 participants | 25 participants | 27 participants |
| Sex: Female, Male Female | 13 Participants | 37 Participants | 13 Participants | 11 Participants |
| Sex: Female, Male Male | 14 Participants | 42 Participants | 12 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 0 / 27 | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 | 0 / 25 |
Outcome results
Primary
Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy
Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP
Time frame: 1 hour
Population: Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brinzolamide/Brimonidine FC | Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy | Baseline | 15.6 mmHg | Standard Deviation 1.5 |
| Brinzolamide/Brimonidine FC | Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy | 1 hour | 13.7 mmHg | Standard Deviation 2 |
| Brimonidine 0.2% | Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy | Baseline | 15.7 mmHg | Standard Deviation 1.5 |
| Brimonidine 0.2% | Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy | 1 hour | 14.7 mmHg | Standard Deviation 3.7 |
| Artificial Tears | Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy | Baseline | 15.2 mmHg | Standard Deviation 1.9 |
| Artificial Tears | Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy | 1 hour | 19.5 mmHg | Standard Deviation 2.9 |
p-value: <0.05ANOVA
Primary
Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy
Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP
Time frame: 1 week
Population: Comparison of intraocular pressure at 1 weekafter Nd-YAG posterior capsulotomy compared to Baseline IOP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brinzolamide/Brimonidine FC | Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy | Baseline | 15.6 mmHg | Standard Deviation 1.5 |
| Brinzolamide/Brimonidine FC | Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy | 1 week | 15.5 mmHg | Standard Deviation 1.1 |
| Brimonidine 0.2% | Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy | Baseline | 15.7 mmHg | Standard Deviation 1.5 |
| Brimonidine 0.2% | Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy | 1 week | 15.3 mmHg | Standard Deviation 1.5 |
| Artificial Tears | Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy | Baseline | 15.2 mmHg | Standard Deviation 1.9 |
| Artificial Tears | Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy | 1 week | 15.6 mmHg | Standard Deviation 1.7 |
p-value: <0.05ANOVA
Primary
Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy
Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Time frame: 24 hours
Population: Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brinzolamide/Brimonidine FC | Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy | Baseline | 15.6 mmHg | Standard Deviation 1.5 |
| Brinzolamide/Brimonidine FC | Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy | 24 hours | 14.6 mmHg | Standard Deviation 1.1 |
| Brimonidine 0.2% | Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy | Baseline | 15.7 mmHg | Standard Deviation 1.5 |
| Brimonidine 0.2% | Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy | 24 hours | 15.5 mmHg | Standard Deviation 1.7 |
| Artificial Tears | Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy | Baseline | 15.2 mmHg | Standard Deviation 1.9 |
| Artificial Tears | Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy | 24 hours | 15.8 mmHg | Standard Deviation 1.8 |
p-value: <0.05ANOVA
Primary
Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy
Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
Time frame: 3 hours
Population: Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brinzolamide/Brimonidine FC | Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy | Baseline | 15.6 mmHg | Standard Deviation 1.5 |
| Brinzolamide/Brimonidine FC | Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy | 3 hours | 12.7 mmHg | Standard Deviation 1.5 |
| Brimonidine 0.2% | Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy | Baseline | 15.7 mmHg | Standard Deviation 1.5 |
| Brimonidine 0.2% | Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy | 3 hours | 14.7 mmHg | Standard Deviation 3.7 |
| Artificial Tears | Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy | Baseline | 15.2 mmHg | Standard Deviation 1.9 |
| Artificial Tears | Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy | 3 hours | 19.5 mmHg | Standard Deviation 2.9 |
p-value: <0.05ANOVA