Trials / Completed
CompletedNCT03677869
Effects of Pneumatic Vitreolysis on Macular Hole
Single-Arm Study Assessing the Effects of Pneumatic Vitreolysis on Macular Hole
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Jaeb Center for Health Research · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion with VMT release and MH closure and to assess factors associated with success.
Detailed description
The objective of this trial is to obtain estimates of the proportion of eyes with MH closure of the inner retinal layers for eyes with VMT and full-thickness MHs treated with PVL. Understanding the rates of VMT release and MH closures in eyes with full-thickness MH treated with PVL is of interest. Surgery would result in nearly 100% hole closure and VMT release, making vitrectomy a poor control group choice. Spontaneous resolution of MH is highly unlikely, making an observation arm unnecessary. Therefore, these eyes will be enrolled into a non-randomized cohort treated with PVL to assess the outcomes of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intraocular gas (C3F8) | Intraocular gas (C3F8) injection |
Timeline
- Start date
- 2018-11-14
- Primary completion
- 2020-03-16
- Completion
- 2020-07-22
- First posted
- 2018-09-19
- Last updated
- 2022-09-19
- Results posted
- 2021-06-29
Locations
45 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03677869. Inclusion in this directory is not an endorsement.