Trial Outcomes & Findings for Effects of Pneumatic Vitreolysis on Macular Hole (NCT NCT03677869)
NCT ID: NCT03677869
Last Updated: 2022-09-19
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
at 8 weeks
Results posted on
2022-09-19
Participant Flow
One eye that did not have full-thickness macular hole was enrolled, received PVL, and completed the 24-week visit but is not included in any analyses or subsequent levels in the participant flow
Participant milestones
| Measure |
Pneumatic Vitreolysis (PVL)
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pneumatic Vitreolysis (PVL)
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Effects of Pneumatic Vitreolysis on Macular Hole
Baseline characteristics by cohort
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 Participants
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-Hispanic Black/African American
|
3 Participants
n=5 Participants
|
|
Diabetes Type
No
|
27 Participants
n=5 Participants
|
|
Diabetes Type
Type 2
|
8 Participants
n=5 Participants
|
|
E-ETDRS visual acuity letter score
|
55.8 units on a scale
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Intraocular pressure
|
16 mmHg
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Lens Status on Clinical Exam
Phakic (natural lens)
|
28 Eyes
n=5 Participants
|
|
Lens Status on Clinical Exam
Prosthetic intraocular lens
|
7 Eyes
n=5 Participants
|
|
Epiretinal membrane in central subfield
|
1 Eyes
n=5 Participants
|
|
Width of vitreomacular attachment that extends within the central subfield
|
325 Microns
n=5 Participants
|
|
Loss of ellipsoid zone integrity in central subfield
|
35 Eyes
n=5 Participants
|
|
Loss of ellipsoid zone integrity in foveal center
|
35 Eyes
n=5 Participants
|
|
Macular hole width at narrowest point
|
79 micron
n=5 Participants
|
PRIMARY outcome
Timeframe: at 8 weeksOutcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy
|
10 Eyes
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksBest-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Outcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline
|
-1.5 units on a scale
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: 8 weeksBest-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent \<20/800). Higher scores indicate better visual acuity and lower scores indicate worse visual acuity.
Outcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
E-ETDRS Visual Acuity Letter Score
|
54.2 units on a scale
Standard Deviation 23.8
|
SECONDARY outcome
Timeframe: up to 8 WeeksOutcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Number of Eyes With Rescue Treatment Before the 8-week Visit
|
12 Eyes
|
SECONDARY outcome
Timeframe: 8 WeeksOutcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Macular Hole Closure Without Rescue Vitrectomy
|
10 Eyes
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Macular Hole Closure With Rescue Vitrectomy
|
10 Eyes
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
No Macular Hole Closure and no Rescue Vitrectomy
|
13 Eyes
|
SECONDARY outcome
Timeframe: 8 weeksOutcome measures
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 Eyes
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
No Macular Hole Closure Despite Rescue Vitrectomy
|
2 Eyes
|
Adverse Events
Pneumatic Vitreolysis (PVL)
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 participants at risk
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Eye disorders
Retinal tear
|
8.6%
3/35 • Number of events 3 • 24-Weeks
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
11.4%
4/35 • Number of events 4 • 24-Weeks
|
|
Vascular disorders
Embolism - blood clot
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
Other adverse events
| Measure |
Pneumatic Vitreolysis (PVL)
n=35 participants at risk
Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.
|
|---|---|
|
Eye disorders
Anterior chamber cell
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Anterior chamber opacity
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Cataract
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Corneal abrasion
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Corneal defect
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Corneal edema
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Corneal pigmentation
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Dry eye
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Eye irritation
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Eye itching
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Eye pain
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Floaters
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Macular hole
|
5.7%
2/35 • Number of events 2 • 24-Weeks
|
|
Eye disorders
Ocular discomfort
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Ocular hypertension
|
11.4%
4/35 • Number of events 4 • 24-Weeks
|
|
Eye disorders
Posterior capsule opacification
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Posterior vitreous detachment
|
5.7%
2/35 • Number of events 2 • 24-Weeks
|
|
Eye disorders
Red eye
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Subconjunctival hemorrhage
|
8.6%
3/35 • Number of events 3 • 24-Weeks
|
|
Eye disorders
Visual acuity decreased
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Visual flashes
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Vitreous debris
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
|
Eye disorders
Vitreous hemorrhage
|
2.9%
1/35 • Number of events 1 • 24-Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place