|Condition or Disease||Intervention / Treatment||Phase||Sponsor||Status|
|Intraocular Gas C3F8||2|| Jaeb Center for|
Eyes with full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL) to determine the proportion MH closure and to assess factors associated with success.
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 full-thickness MHs treated with PVL. Surgery would result in nearly 100% hole closure, 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.
Study Eye Criteria: The participant must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria listed below. A participant can have only one study eye. If both eyes are eligible at the time of enrollment, the study eye will be selected by the investigator and participant before injection.
Inclusion - Study Eye:
Beachwood Office - Janine Davis 216-831-5700 • email@example.com
Middleburg Heights Office - Susan Rath 440-663-0022 • firstname.lastname@example.org