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

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

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

Study Overview

• Status: Completed
• Conditions: Scleral Buckling
• Intervention / Treatment: Drug: standard post-operative topical drops; Drug: Timolol-dorzolamide (Glaucoma drops)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina- Wills Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Post surgery without glaucoma 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.	Drug: standard post-operative topical drops; Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim; Other Names: standard of care; corticosteroid; prednisolone; glaucoma; drops; oral; Polymyxin B; trimethoprim
Experimental: Post surgery with 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.	Drug: standard post-operative topical drops; Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim; Other Names: standard of care; corticosteroid; prednisolone; glaucoma; drops; oral; Polymyxin B; trimethoprim; Drug: Timolol-dorzolamide (Glaucoma drops); Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.; Other Names: timol; glaucoma drops; dorzolamide; timol-dorzolamide

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jason Hsu, MD
• Investigators: Principal Investigator: Jason Hsu, MD, Wills Eye Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): May 1, 2013

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: topical; eye; pneumatic retinopexy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Anti-Infective Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Carbonic Anhydrase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Anti-Dyskinesia Agents; Anti-Infective Agents, Urinary; Renal Agents; Cytochrome P-450 CYP2C8 Inhibitors; Prednisolone; Timolol; Dorzolamide; Trimethoprim; Polymyxins; Polymyxin B
• Other Study ID Numbers: 11095 Gas Duration; 11-095 (Wills Eye IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No