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

• Sponsor: Mid Atlantic Retina (Other)
• Overall Status: Completed
• CT.gov ID: NCT01257698
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase
Macular Hole; Retinal Detachment	Drug: Dorzolamide 2%-timolol 0.5% topical eyedrops	N/A

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 Design

• Study Type: Interventional
• 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: Feb 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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 Names: Cosopt
No Intervention: Standard of care

Outcome Measures

Primary Outcome Measures

1. Duration of Intraocular Gas [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wills Eye Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Mid Atlantic Retina

Investigators

• Principal Investigator: Jason Hsu, MD, Mid Atlantic Retina

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Michele Formoso, Research Manager, Mid Atlantic Retina
• ClinicalTrials.gov Identifier: NCT01257698
• Other Study ID Numbers: 09-935
• First Posted: Dec 10, 2010
• Last Update Posted: Sep 4, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Michele Formoso, Research Manager, Mid Atlantic Retina: Vitrectomy; Gas bubble; Retinal detachment; Macular hole; Aqueous suppressant
• Additional relevant MeSH terms: Retinal Detachment; Retinal Perforations; Timolol; Dorzolamide; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	Dorzolamide-timolol Topical Drops	Standard of Care
Arm/Group Description	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.	Standard post-operative drops
Period Title: Overall Study
STARTED	12	9
COMPLETED	8	9
NOT COMPLETED	4	0

Baseline Characteristics

Arm/Group Title	Dorzolamide-timolol Topical Drops	Standard of Care	Total
Arm/Group Description	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.	Standard post-operative drops	Total of all reporting groups
Overall Participants	8	9	17
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 87.5%	6 66.7%	13 76.5%
>=65 years	1 12.5%	3 33.3%	4 23.5%
Sex: Female, Male (Count of Participants)
Female	3 37.5%	0 0%	3 17.6%
Male	5 62.5%	9 100%	14 82.4%
Region of Enrollment (participants) [Number]
United States	8 100%	9 100%	17 100%

Outcome Measures

1. Primary Outcome

Title	Duration of Intraocular Gas
Description	Patients will self-monitor gas bubble duration and will receive weekly phone calls by the study coordinator until gas disappearance is confirmed.
Time Frame	Up to 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dorzolamide-timolol Topical Drops	Standard of Care
Arm/Group Description	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.
Measure Participants	8	9
Mean (Standard Deviation) [days]	17.1 (1.6)	18.1 (2.4)

Adverse Events

Arm/Group Title	Dorzolamide-timolol Topical Drops		Standard of Care
Arm/Group Description	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.		Standard post-operative drops
All Cause Mortality
	Dorzolamide-timolol Topical Drops		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)
Serious Adverse Events
	Dorzolamide-timolol Topical Drops		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Dorzolamide-timolol Topical Drops		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.