Effects of Pneumatic Vitreolysis on Macular Hole

NCT ID: NCT03677869

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-14
• Study Completion Date: 2020-07-22

Brief Summary

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

Detailed Description

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.

Conditions

Vitreomacular Traction (VMT); Full-thickness Macular Holes (MH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pneumatic vitreolysis (PVL)

Pneumatic vitreolysis is an in-office intraocular injection of an expansile gas (C3F8) to induce release of vitreomacular traction.

Group Type: EXPERIMENTAL

Intraocular gas (C3F8)

Intervention Type: DEVICE

Intraocular gas (C3F8) injection

Interventions

Intraocular gas (C3F8)

Intraocular gas (C3F8) injection

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Calvin E Mein, MD

Role: STUDY_CHAIR

Retinal Consultants of San Antonio

Locations

Retinal Diagnostic Center

Campbell, California, United States

Atlantis Eye Care

Huntington Beach, California, United States

Northern California Retina Vitreous Associates

Mountain View, California, United States

East Bay Retina Consultants, Inc.

Oakland, California, United States

Southern California Desert Retina Consultants, MC

Palm Desert, California, United States

National Ophthalmic Research Institute

Fort Myers, Florida, United States

University of Florida College of Med., Dept of Ophthalmology, Jacksonville Hlth Sci Ctr

Jacksonville, Florida, United States

Florida Retina Consultants

Lakeland, Florida, United States

Florida Retina Institute

Orlando, Florida, United States

Southeast Eye Institute, PA dba Eye Associates of Pinellas

Pinellas Park, Florida, United States

Retina Associates of Sarasota

Sarasota, Florida, United States

Sarasota Retina Institute

Sarasota, Florida, United States

Southeast Retina Center, PC

Augusta, Georgia, United States

Thomas Eye Group

Sandy Springs, Georgia, United States

Gailey Eye Clinic

Bloomington, Illinois, United States

University of Illinois at Chicago Medical Center

Chicago, Illinois, United States

Illinois Retina Associates, SC

Oak Park, Illinois, United States

Carle Foundation Hospital

Urbana, Illinois, United States

Raj K. Maturi, MD, PC

Indianapolis, Indiana, United States

Wolfe Eye Clinic

West Des Moines, Iowa, United States

Mid-America Retina Consultants, P.A.

Overland Park, Kansas, United States

Paducah Retinal Center

Paducah, Kentucky, United States

Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

West Monroe, Louisiana, United States

Elman Retina Group, BA

Baltimore, Maryland, United States

Valley Eye Physicians and Surgeons

Ayer, Massachusetts, United States

Joslin Diabetes Center

Boston, Massachusetts, United States

Vitreo-Retinal Associates, PC

Worcester, Massachusetts, United States

Retina Specialists of Michigan

Grand Rapids, Michigan, United States

Mayo Clinic Department of Ophthalmology

Rochester, Minnesota, United States

The Retina Institute

St Louis, Missouri, United States

MaculaCare

New York, New York, United States

Retina-Vitreous Surgeons of Central New York, PC

Syracuse, New York, United States

Western Carolina Clinical Research, LLC

Asheville, North Carolina, United States

Charlotte Eye, Ear, Nose, and Throat Assoc., PA

Charlotte, North Carolina, United States

Retina Associates of Cleveland, Inc.

Beachwood, Ohio, United States

Retina Vitreous Center

Edmond, Oklahoma, United States

Oregon Retina, LLP

Eugene, Oregon, United States

Retina Northwest, PC

Portland, Oregon, United States

Southeastern Retina Associates

Chattanooga, Tennessee, United States

Southeastern Retina Associates, PC

Knoxville, Tennessee, United States

Austin Retina Associates

Austin, Texas, United States

Retina Research Center

Austin, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Retinal Consultants of San Antonio

San Antonio, Texas, United States

Spokane Eye Clinic

Spokane, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U10EY014231

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DRCR.net Protocol AH

Identifier Type: -

Identifier Source: org_study_id