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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.
Required follow-up for this study is 3 months post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 27-gauge pak | Experimental | CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery |
|
| 23-gauge pak | Active Comparator | CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CONSTELLATION® 27-gauge Combined Surgical Pak | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 preoperative, Day 0 postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Surgical, GCRA | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 137 enrolled, 1 subject was exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (136).
Subjects were recruited from 6 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | 27-Gauge | CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery |
| FG001 | 23-Gauge | CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This analysis population includes all randomized subjects (Intent-to-Treat Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | 27-Gauge | CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery |
| BG001 | 23-Gauge | CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery |
| Units | Counts |
|---|---|
| Participants |
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| 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 | 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. | Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data. | Posted | Mean | Standard Deviation | mmHG | Day 0 preoperative, Day 0 postoperative |
|
Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 4 months).
An AE was defined as any untoward medical occurrence in a subject administered a clinical trial treatment (ie, implant with an investigational device) regardless of whether the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. Safety analysis set included all subjects/eyes exposed to the investigational device. One subject randomized to 27-gauge was treated with 23-gauge instead.
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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 | 27-Gauge Treated Eye | Ocular events, treated (study) eye | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brand Lead, Global Medical Affairs | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| CONSTELLATION® 23-gauge Combined Surgical Pak | Device | 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. |
|
| Vitrectomy surgery | Procedure | Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases |
|
| Week 1 post operative |
| 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. | Day 1 post operative |
| Withdrawal by Subject |
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| Administered gas during surgery |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
|
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| 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. | Intent-to-Treat Set. Number Analyzed is the number of subjects with data. | Posted | Mean | Standard Deviation | units on a scale | Week 1 post operative |
|
|
|
| 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. | Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data. | Posted | Mean | Standard Deviation | units on a scale | Day 1 post operative |
|
|
|
| 66 |
| 15 |
| 66 |
| 18 |
| 66 |
| EG001 | 27-Gauge Fellow Eye | Ocular events, untreated (fellow) eye | 0 | 66 | 0 | 66 | 0 | 66 |
| EG002 | 27-Gauge Systemic | Non-ocular adverse events | 0 | 66 | 0 | 66 | 0 | 66 |
| EG003 | 23-Gauge Treated Eye | Ocular events, treated (study) eye | 0 | 69 | 16 | 69 | 14 | 69 |
| EG004 | 23-Gauge Fellow Eye | Ocular events, untreated (fellow) eye | 0 | 69 | 0 | 69 | 0 | 69 |
| EG005 | 23-Gauge Systemic | Non-ocular adverse events | 0 | 69 | 1 | 69 | 0 | 69 |
| Hypotony of eye | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Macular fibrosis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Macular hole | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Retinal tear | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Retinopathy proliferative | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Intraocular pressure decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Craniotomy | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
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| Eye laser surgery | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
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| Eye operation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
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| Retinal laser coagulation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
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| Retinal operation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
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| Vitrectomy | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
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| Conjunctival oedema | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (18.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.