Vitreoretinal Disease
Conditions
Brief summary
The purpose of this study is to compare the treatment day change between immediate postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and 23-gauge vitrectomy instruments.
Detailed description
Required follow-up for this study is 3 months post treatment.
Interventions
DEVICECONSTELLATION® 27-gauge Combined Surgical Pak
Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 27-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 27-gauge EDGEPLUS® Valved Entry System comprised of 3 trocar/cannulas and related accessories.
DEVICECONSTELLATION® 23-gauge Combined Surgical Pak
Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 23-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 23-gauge EDGEPLUS® trocar/cannula set comprising of 3 trocars/cannulas and related accessories.
PROCEDUREVitrectomy surgery
Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to provide informed consent and attend all required study visits; * Requires vitrectomy in at least one eye; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Previous vitrectomy or glaucoma surgery; * Planned treatment requires scleral buckling, combined procedures (eg, cataract surgery), silicone oil, and expansive gas other than sterile air; * Treated with topical IOP lowering medication(s) at any time from baseline assessment to time of surgery; * Pregnant or planning to become pregnant during the course of the trial; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Intraocular Pressure (IOP) on Operative Day | Day 0 preoperative, Day 0 postoperative | IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Conjunctival Edema Score at Week 1 | Week 1 post operative | Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis. |
| Mean Post-operative Pain Rating at Day 1 | Day 1 post operative | The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 6 study centers located in the US.
Pre-assignment details
Of the 137 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (136).
Participants by arm
| Arm | Count |
|---|---|
| 27-Gauge CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery | 68 |
| 23-Gauge CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery | 68 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administered gas during surgery | 0 | 1 |
| Overall Study | Discontinued prior to treatment | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 27-Gauge | 23-Gauge | Total |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 11.55 | 67.0 years STANDARD_DEVIATION 11.65 | 66.4 years STANDARD_DEVIATION 11.57 |
| Sex: Female, Male Female | 43 Participants | 45 Participants | 88 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 | 0 / 66 | 0 / 69 | 0 / 69 | 0 / 69 |
| other Total, other adverse events | 18 / 66 | 0 / 66 | 0 / 66 | 14 / 69 | 0 / 69 | 0 / 69 |
| serious Total, serious adverse events | 15 / 66 | 0 / 66 | 0 / 66 | 16 / 69 | 0 / 69 | 1 / 69 |
Outcome results
Primary
Mean Change in Intraocular Pressure (IOP) on Operative Day
IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.
Time frame: Day 0 preoperative, Day 0 postoperative
Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 27-Gauge | Mean Change in Intraocular Pressure (IOP) on Operative Day | -0.40 mmHG | Standard Deviation 6.603 |
| 23-Gauge | Mean Change in Intraocular Pressure (IOP) on Operative Day | -3.05 mmHG | Standard Deviation 7.639 |
Secondary
Mean Conjunctival Edema Score at Week 1
Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis.
Time frame: Week 1 post operative
Population: Intent-to-Treat Set. Number Analyzed is the number of subjects with data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 27-Gauge | Mean Conjunctival Edema Score at Week 1 | 0.02 units on a scale | Standard Deviation 0.124 |
| 23-Gauge | Mean Conjunctival Edema Score at Week 1 | 0.10 units on a scale | Standard Deviation 0.246 |
Secondary
Mean Post-operative Pain Rating at Day 1
The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable.
Time frame: Day 1 post operative
Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 27-Gauge | Mean Post-operative Pain Rating at Day 1 | 0.9 units on a scale | Standard Deviation 1.75 |
| 23-Gauge | Mean Post-operative Pain Rating at Day 1 | 0.6 units on a scale | Standard Deviation 1.2 |