The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble

Not Applicable

Completed

• Conditions: Scleral Buckling
• Interventions: Drug: standard post-operative topical drops; Drug: Timolol-dorzolamide (Glaucoma drops)

• Registration Number: NCT01843920
• Lead Sponsor: Jason Hsu, MD

Brief Summary

A controlled clinical study comparing the effect of topical aqueous suppressants on intraocular gas duration.

Detailed Description

A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration following Scleral Buckling and Pneumatic Retinopexy

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-05-01
• Results First Submitted: 2014-05-27
• Results First Submitted QC: 2016-12-13
• Results First Posted: 2017-02-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Have undergone eye surgery including scleral buckling or pneumatic retinopexy for treatment of retinal detachment other condition at the discretion of the investigator.

Exclusion Criteria

• Prior surgery to treat glaucoma.
• Current use of glaucoma eye drops.
• Absence of a lens in the eye or presence of a lens implant in front of the iris (colored part of your eye).
• Allergy or contraindication to any of the glaucoma drops being used in this study (e.g., sulfa allergy, asthma, chronic obstructive pulmonary disease (bronchitis or emphysema), slow heart rate).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post surgery without glaucoma drops	standard post-operative topical drops	This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.
Post surgery with glaucoma drops	Timolol-dorzolamide (Glaucoma drops)	This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Post surgery with glaucoma drops	standard post-operative topical drops	This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.

Primary Outcome Measures

Name	Time	Method
Complete Resolution of Intraocular Gas Bubble	Following surgery, until gas bubble is gone. Up to 2 months.	This will be reported by the patient when they see/feel the gas bubble disappear.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Return of Intraocular Pressure to Normal Levels	Month 2	Number of participants with a normal intraocular pressure of 10-21 mm Hg at the Month 2 visit

Trial Locations

Locations (1)

Mid Atlantic Retina- Wills Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States