Effects of Pneumatic Vitreolysis on Macular Hole

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.

Participant-Level Criteria Inclusion

To be eligible, the following inclusion criteria must be met:

1. Age ≥ 18 years

• Participants < 18 years old are not being included because the condition is so rare
in this age group that the diagnosis may be questionable.

2. At least one eye meets the study eye criteria

3. Able and willing to provide informed consent

4. Able and willing to avoid high altitude travel, including airline travel, until gas
resolution (approximately 6 to 8 weeks)

5. For phakic patients, able and willing to avoid supine position until gas resolution
(approximately 6 to 8 weeks)

6. Able and willing to position face down for at least 50% of the time for at least 4
days post-injection (to facilitate macular hole closure)

7. Able and willing to wear wristband that informs any medical personnel that the patient
has a gas bubble in the eye Exclusion

A potential participant is not eligible if any of the following exclusion criteria are
present:

8. A condition that, in the opinion of the investigator, would preclude participation in
the study (e.g., unstable medical status that might preclude completion of follow up) 9.
Participation in an investigational trial within 30 days of enrollment that involves
treatment with any drug or device that has not received regulatory approval for the
indication being studied at the time of study entry

- Note: study participants should not receive another investigational drug or device
while participating in the study 10. Known contraindication to any component of the
treatment 11. Known allergy to any drug used in the procedure prep (including povidone
iodine) 12. Potential participant is expecting to move out of the area of the clinical
center to an area not covered by another clinical center during the 6 months following
enrollment 13. Anticipated surgery requiring anesthesia within the 6 months following
enrollment

- Participants cannot receive nitrous oxide until gas resolution 13. For women of
child-bearing potential: pregnant at the time of enrollment

- Women who are potential study participants should be questioned about the potential
for pregnancy. Investigator judgement may be used to determine when a pregnancy test
is needed

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.

The eligibility criteria for a study eye are as follows:

Inclusion

1. Full-thickness macular hole that is ≤ 250 microns at the narrowest point, confirmed by
central reading center

2. Vitreomacular adhesion on OCT that is no larger than 3000 microns with visible
separation of the vitreous on either side as seen on horizontal and vertical scans ,
confirmed by central reading center

• Presence of epiretinal membrane is neither a requirement nor exclusion

3. Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or
better) and at most 83 (20/25 or worse) Exclusion

4. Other ocular condition that might affect visual acuity during the course of the study
or require intraocular treatment (e.g., retinal vein occlusion, substantial
age-related macular degeneration, or macular edema induced by a condition other than
VMT)

- If diabetic retinopathy is present, severity level must be microaneurysms only or
better (≤ diabetic retinopathy severity level 20).

- Presence of drusen is acceptable; however, eyes with geographic atrophy or
neovascular age-related macular degeneration involving the macula are excluded.

5. High level of myopia (spherical equivalent of -8.00 diopters or more myopic if phakic,
or retinal abnormalities consistent with pathologic myopia if phakic or pseudophakic)

6. History of prior gas injection, ocriplasmin injection, or intraocular injection for
any reason

7. History of prior vitrectomy

8. History of uncontrolled glaucoma

• Intraocular pressure must be < 30 mmHg, with no more than one topical glaucoma
medication, and no documented glaucomatous field loss for the eye to be eligible

9. History of major ocular surgery (including cataract extraction, scleral buckle, any
intraocular surgery, etc.) within prior 4 months or major ocular surgery anticipated
within the next 6 months following enrollment

10. History of YAG capsulotomy performed within 4 months prior to enrollment

11. Aphakia or anterior chamber intraocular lens

12. Exam evidence of severe external ocular infection, including conjunctivitis,
chalazion, or substantial blepharitis

13. Uveitis

14. Retinal history or pathology that might predispose an eye to an increased risk of
retinal detachment from the procedure

• Untreated retinal tears, not retinal holes, are an exclusion. It is up to the
investigator to determine whether extent of lattice degeneration or other pathology
might increase the risk of retinal detachment

15. Any contraindication to paracentesis (e.g., history of narrow angle glaucoma)

16. Lenticular or zonular instability