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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michele Formoso, Mid Atlantic Retina
ClinicalTrials.gov Identifier:
NCT01257698
First received: December 8, 2010
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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 Intervention
Macular Hole
Retinal Detachment
Drug: Dorzolamide 2%-timolol 0.5% topical eyedrops

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mid Atlantic Retina:

Primary Outcome Measures:
  • Duration of intraocular gas [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Patients will self-monitor gas bubble duration and will receive weekly phone calls by the study coordinator until gas disappearance is confirmed.


Enrollment: 21
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257698

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

Publications:
Responsible Party: Michele Formoso, Research Manager, Mid Atlantic Retina
ClinicalTrials.gov Identifier: NCT01257698     History of Changes
Other Study ID Numbers: MAR-2
Study First Received: December 8, 2010
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mid Atlantic Retina:
Vitrectomy
Gas bubble
Retinal detachment
Macular hole
Aqueous suppressant

Additional relevant MeSH terms:
Retinal Perforations
Retinal Detachment
Retinal Diseases
Eye Diseases
Timolol
Dorzolamide
Tetrahydrozoline
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014