Effects of Pneumatic Vitreolysis on Vitreomacular Traction
Condition: Vitreomacular Traction
Intervention: Pneumatic Vitreolysis (C3F8 injection); Observation
Intervention description: Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina.; No intervention; sham injection only
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Visual acuity and optical coherence tomography technicians will be masked to treatment group at all visits. The goal is for study participants to remain masked to their treatment group assignment, although it is likely that the gas bubble will be visible to participants in the pneumatic vitreolysis group. Investigators and study coordinators are not masked to treatment group.
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be
      randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine
      if pneumatic vitreolysis (PVL) is effective in releasing VMT.
    

Eligibility criteria:

        Inclusion Criteria:

          1. At least one eye meets the study eye criteria listed below.

          2. Able and willing to provide informed consent.

          3. Able and willing to avoid high altitude travel, including airline travel, until gas
             resolution (approximately 6 to 8 weeks).

          4. For phakic patients, able and willing to avoid supine position until gas resolution
             (approximately 6 to 8 weeks).

          5. 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:

          6. 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)

          7. Participation in an investigational trial within 30 days of randomization 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/device
             while participating in the study

          8. Known contraindication to any component of the treatment

          9. Known allergy to any drug used in the procedure prep (including povidone iodine)

         10. 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 next 6 months following
             randomization

         11. Anticipated surgery requiring anesthesia within the next 6 months following
             randomization

             • Participants cannot receive nitrous oxide until gas resolution

         12. 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
             randomization, the study eye will be selected by the investigator and participant
             before randomization.

             The eligibility criteria for a study eye are as follows:

             Inclusion

               1. 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 Note: presence of epiretinal membrane
                  is neither a requirement nor exclusion.

               2. Decreased visual function (e.g. metamorphopsia or other visual symptom) that is
                  attributed to VMT.

             Examples of visual symptoms include:

             a) Distortion and/or reduction in visual acuity b) Recognized difficulty with reading,
             driving, or using a computer c) Patient recognized interference with quality of life
             because of a and/or b.

             c. Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or
             better) and at most 78 (20/32 or worse) d. Investigator and participant willing to
             wait 6 months before surgical intervention, provided visual acuity remains stable

             • An eye that requires prompt treatment for VMT should not be enrolled

             Exclusion e. 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 f. 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) g.
             History of prior gas injection, ocriplasmin injection, or intraocular injection for
             any reason h. History of prior vitrectomy i. History of uncontrolled glaucoma

             • IOP must be <30 mmHg, with no more than one topical glaucoma medication, and no
             documented glaucomatous field loss for the eye to be eligible j. 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 randomization k. History of YAG capsulotomy performed within 4
             months prior to randomization l. Aphakia or anterior chamber intraocular lens m. Exam
             evidence of severe external ocular infection, including conjunctivitis, chalazion, or
             substantial blepharitis n. Uveitis o. Presence of any macular hole or lamellar hole
             (according to reading center grading) p. 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.

             q. Any contraindication to paracentesis (e.g., history of narrow angle glaucoma) r.
             Lenticular or zonular instability