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

NCT ID: NCT01257698

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Macular Hole; Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dorzolamide-timolol topical drops

Group Type: ACTIVE_COMPARATOR

Dorzolamide 2%-timolol 0.5% topical eyedrops

Intervention Type: DRUG

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.

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Cosopt

Eligibility 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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mid Atlantic Retina

OTHER

Sponsor Role: lead

Responsible Party

Michele Formoso

Research Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Mid Atlantic Retina

Locations

Wills Eye Institute

Philadelphia, Pennsylvania, United States

Countries

United States

References

Lee MS, Pasha M, Weitzman M. The effect of aqueous humor suppressants on intravitreal gas bubble duration in rabbits. Am J Ophthalmol. 1998 May;125(5):701-2. doi: 10.1016/s0002-9394(98)00006-3.

Reference Type: BACKGROUND

PMID: 9625556 (View on PubMed)

Mittra RA, Pollack JS, Dev S, Han DP, Mieler WF, Pulido JS, Connor TB. The use of topical aqueous suppressants in the prevention of postoperative intraocular pressure elevation after pars plana vitrectomy with long-acting gas tamponade. Ophthalmology. 2000 Mar;107(3):588-92. doi: 10.1016/s0161-6420(99)00083-4.

Reference Type: BACKGROUND

PMID: 10711900 (View on PubMed)

Benz MS, Escalona-Benz EM, Murray TG, Eifrig CW, Yoder DM, Moore JK, Schiffman JC. Immediate postoperative use of a topical agent to prevent intraocular pressure elevation after pars plana vitrectomy with gas tamponade. Arch Ophthalmol. 2004 May;122(5):705-9. doi: 10.1001/archopht.122.5.705.

Reference Type: BACKGROUND

PMID: 15136318 (View on PubMed)

Shah CP, Hsu J, Spirn MJ, Donoso L, Garg SJ. Topical aqueous suppression does not significantly affect duration of intraocular gas tamponade after vitrectomy. Retina. 2012 Jan;32(1):168-71. doi: 10.1097/IAE.0b013e31822092a4.

Reference Type: RESULT

PMID: 21878847 (View on PubMed)

Other Identifiers

09-935

Identifier Type: -

Identifier Source: org_study_id