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 Full-thickness macular hole that is ≤ 250 microns at the narrowest point, confirmed by central reading center 2. The eligibility criteria for a study eye are as follows: Inclusion 1. If both eyes are eligible at the time of enrollment, the study eye will be selected by the investigator and participant before injection. A participant can have only one study eye. 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. 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. Anticipated surgery requiring anesthesia within the 6 months following enrollment - Participants cannot receive nitrous oxide until gas resolution 13. 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. Known allergy to any drug used in the procedure prep (including povidone iodine) 12. Known contraindication to any component of the treatment 11.
#Vmt retina trial#
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. 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. 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. 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. For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks) 6. Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks) 5. Able and willing to provide informed consent 4. At least one eye meets the study eye criteria 3. Participants Participant-Level Criteria Inclusion To be eligible, the following inclusion criteria must be met: 1. Intervention Name: Intraocular gas (C3F8) No Macular Hole Closure Despite Rescue Vitrectomy No Macular Hole Closure and no Rescue Vitrectomy Macular Hole Closure With Rescue Vitrectomy Macular Hole Closure Without Rescue Vitrectomy Number of Eyes With Rescue Treatment Before the 8-week Visit Mean Change in E-ETDRS Visual Acuity Letter Score From Baseline Proportion of Eyes With Macular Hole Closure of Inner Retinal Layers Without Rescue Vitrectomy Therefore, these eyes will be enrolled into a non-randomized cohort treated with PVL to assess the outcomes of treatment.
Spontaneous resolution of MH is highly unlikely, making an observation arm unnecessary. Surgery would result in nearly 100% hole closure and VMT release, making vitrectomy a poor control group choice. Understanding the rates of VMT release and MH closures in eyes with full-thickness MH treated with PVL is of interest. 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.
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