A Study of the Effects of Pneumatic Vitreolysis on Macular Hole

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 18-007474
    NCT ID: NCT03677869
    Sponsor Protocol Number: DRCR.net Protocol AH

About this study

The purpose of this study is to determine the proportion with VMT release and MH closure and to assess factors associated with success.  Eyes with vitreomacular traction (VMT) and full-thickness macular holes (MH) will be enrolled into a non-randomized cohort treated with pneumatic vitreolysis (PVL).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Participant-Level Inclusion Criteria:

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

  • 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.
  • At least one eye meets the study eye criteria.
  • Able and willing to provide informed consent.
  • Able and willing to avoid high altitude travel, including airline travel, until gas resolution (approximately 6 to 8 weeks).
  • For phakic patients, able and willing to avoid supine position until gas resolution (approximately 6 to 8 weeks).
  • 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).
  • Able and willing to wear wristband that informs any medical personnel that the patient has a gas bubble in the eye.

Exclusion Criteria:

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

  • 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).
  • 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.
  • Known contraindication to any component of the treatment.
  • Known allergy to any drug used in the procedure prep (including povidone iodine).
  • 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.
  • Anticipated surgery requiring anesthesia within the 6 months following enrollment. 
    • Participants cannot receive nitrous oxide until gas resolution.
  • 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 Criteria:

  • Full-thickness macular hole that is ≤ 250 microns at the narrowest point, confirmed by central reading center.
  • 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.
  • Visual acuity letter score of at least 19 (approximate Snellen equivalent 20/400 or better) and at most 83 (20/25 or worse).

Exclusion Criteria:

  • 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.
  • 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) .
  • History of prior gas injection, ocriplasmin injection, or intraocular injection for any reason.
  • History of prior vitrectomy.
  • 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.
  • 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.
  • History of YAG capsulotomy performed within 4 months prior to enrollment.
  • Aphakia or anterior chamber intraocular lens.
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis.
  • Uveitis.
  • 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.
  • Any contraindication to paracentesis (e.g., history of narrow angle glaucoma).
  • Lenticular or zonular instability.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrew Barkmeier, M.D.

Open for enrollment

Contact information:

Hamad Gul

(507)284-5833

Gul.Hamad@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20449553

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