Effect of Topical Aqueous Suppressants on Intraocular Gas Duration Following Pars Plana Vitrectomy
|ClinicalTrials.gov Identifier: NCT01257698|
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : February 9, 2012
|Condition or disease||Intervention/treatment|
|Macular Hole Retinal Detachment||Drug: Dorzolamide 2%-timolol 0.5% topical eyedrops|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257698
|United States, Pennsylvania|
|Wills Eye Institute|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Jason Hsu, MD||Mid Atlantic Retina|