Effect of Topical Aqueous Suppressants on Intraocular Gas Duration Following Pars Plana Vitrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01257698
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : February 9, 2012
Information provided by (Responsible Party):
Michele Formoso, Mid Atlantic Retina

Brief Summary:
The purpose of this study is to see if glaucoma eye drops (dorzolamide-timolol) have any effect on the duration of an intraocular gas bubble following pars plana vitrectomy.

Condition or disease Intervention/treatment
Macular Hole Retinal Detachment Drug: Dorzolamide 2%-timolol 0.5% topical eyedrops

Detailed Description:

At the end of some retinal surgeries, a gas bubble is placed in the eye. In surgeries for retinal detachment, this gas bubble helps to keep the tear(s) in the retina sealed up while the eye is healing and prevent the retina from re-detaching. In macular hole surgeries (a defect in the center part of the retina), the gas bubble helps to seal up this hole in the center part of the retina. The gas bubble (sulfur hexafluoride) will slowly disappear from the eye over the course of approximately 2 weeks.

In some cases, the gas bubble disappears more quickly than the surgeon would wish. Several eye drops are currently available which help to lower the eye pressure in conditions such as glaucoma where the eye pressure is unacceptably elevated and is causing or may cause vision loss. These drops have been shown to keep the eye pressure controlled after surgery with injection of a gas bubble in the eye. However, little is known about the effect of these drops on the duration of the gas bubble. The goal of this study is to see if these glaucoma eye drops have any effect on the amount of time the gas bubble remains in the eye.

After surgery with a gas bubble (sulfur hexafluoride) is completed, patients will be randomly assigned (like a flip of a coin) to receive a glaucoma drop (dorzolamide-timolol) or no glaucoma drop. These drops are currently available from pharmacies with a prescription and are not "experimental." However, the use of these drops in this protocol is not to treat glaucoma but represents an "off-label" use. Patients assigned to receive a glaucoma drop will be provided with the medication. All patients will receive the standard post-operative drops regardless of which group they are assigned to. Patients will be taken care of before and after the surgery like any other patient undergoing this procedure. The investigators expect that you will be enrolled in this study for 3 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration Following Pars Plana Vitrectomy
Study Start Date : February 2010
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Dorzolamide-timolol topical drops Drug: Dorzolamide 2%-timolol 0.5% topical eyedrops
Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
Other Name: Cosopt
No Intervention: Standard of care

Primary Outcome Measures :
  1. Duration of intraocular gas [ Time Frame: Up to 4 weeks ]
    Patients will self-monitor gas bubble duration and will receive weekly phone calls by the study coordinator until gas disappearance is confirmed.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled for pars plana vitrectomy with intraocular gas tamponade with sulfur hexafluoride (e.g., retinal detachment, macular hole, other condition at the discretion of the investigator).
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

  • Prior trabeculectomy or tube shunt surgery.
  • Current use of topical aqueous suppressants or other glaucoma medications.
  • Aphakia or presence of anterior chamber intraocular lens implant.
  • Known allergy or contraindication to sulfa or beta-blocker use (e.g., asthma, chronic obstructive pulmonary disease, bradycardia).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01257698

United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Mid Atlantic Retina
Principal Investigator: Jason Hsu, MD Mid Atlantic Retina

Responsible Party: Michele Formoso, Research Manager, Mid Atlantic Retina Identifier: NCT01257698     History of Changes
Other Study ID Numbers: MAR-2
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012

Keywords provided by Michele Formoso, Mid Atlantic Retina:
Gas bubble
Retinal detachment
Macular hole
Aqueous suppressant

Additional relevant MeSH terms:
Retinal Detachment
Retinal Perforations
Retinal Diseases
Eye Diseases
Ophthalmic Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmaceutical Solutions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors