Scleral BucklingNCT01843920
The Effect of Glaucoma Drops on of the Duration of a Pure Intraocular Gas Bubble
A study testing Timolol-dorzolamide (Glaucoma drops) and standard post-operative topical drops in people with Scleral Buckling, run by Jason Hsu, MD at 1 site in United States.
Trial summary
A controlled clinical study comparing the effect of topical aqueous suppressants on intraocular gas duration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleral Buckling
- What is being tested?
- Timolol-dorzolamide (Glaucoma drops) and standard post-operative topical drops
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
Read the detailed description
A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration following Scleral Buckling and Pneumatic Retinopexy
- Conditions
- Scleral Buckling
- Being tested
- Timolol-dorzolamide (Glaucoma drops), standard post-operative topical drops
- Keywords
- eye, pneumatic retinopexy, topical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timolol-dorzolamide (Glaucoma drops)Drug
Also called timol, glaucoma drops, dorzolamide, timol-dorzolamide
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.
standard post-operative topical dropsDrug
Also called glaucoma, drops, standard of care, oral
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
| Study group | Role | What they receive |
|---|---|---|
| Post surgery without glaucoma drops | Active comparator | 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. Receives: Drug: standard post-operative topical drops |
| Post surgery with glaucoma drops | Experimental | 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. Receives: Drug: Timolol-dorzolamide (Glaucoma drops); Drug: standard post-operative topical drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Resolution of Intraocular Gas Bubble
This will be reported by the patient when they see/feel the gas bubble disappear.
Measured: Following surgery, until gas bubble is gone. Up to 2 months.
Secondary outcomes (1)
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
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startJun 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Scleral BucklingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Hsu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jason Hsu, MD, Wills Eye
- Investigators
- Jason Hsu, MD, Principal investigator, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843920
- Sponsor's protocol ID
- 11095 Gas Duration
- Other IDs
- 11-095
- Status last verified
- Apr 2018
- First submitted
- 18 Apr 2013
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration Following Scleral Buckling and Pneumatic Retinopexy.
- ClinicalTrials.gov ID
- NCT01843920
- Acronym / sponsor ID
- 11095 Gas Duration
- Conditions
- Scleral Buckling
- Keywords
- eye, pneumatic retinopexy, topical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jason Hsu, MDUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post surgery without glaucoma drops | Active comparator | Drug: standard post-operative topical dropsThis 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 | Experimental | Drug: Timolol-dorzolamide (Glaucoma drops), Drug: standard post-operative topical dropsThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Timolol-dorzolamide (Glaucoma drops)Also: timol, glaucoma drops, dorzolamide, timol-dorzolamidePatients 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. | Drug | Post surgery with glaucoma drops |
| standard post-operative topical dropsAlso: glaucoma, drops, standard of care, oralPatients 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 | Drug | Post surgery with glaucoma drops, Post surgery without glaucoma drops |
Primary outcome
Complete Resolution of Intraocular Gas Bubble
Time frame: 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.
1 secondary outcome
Number of Participants With Return of Intraocular Pressure to Normal Levels
Time frame: Month 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Scleral Buckling
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Choroidal Venous Congestion Following Scleral Buckling - An Imaging Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Hsu, MD principal investigator
Wills Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timolol-dorzolamide (Glaucoma drops) and standard post-operative topical drops in people with Scleral Buckling, run by Jason Hsu, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Resolution of Intraocular Gas Bubble (time frame: Following surgery, until gas bubble is gone. Up to 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.