NCT01843920

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

February 6, 2017

Completed
Last Updated

May 30, 2018

Status Verified

April 1, 2018

Enrollment Period

1.8 years

First QC Date

April 18, 2013

Results QC Date

May 27, 2014

Last Update Submit

April 30, 2018

Conditions

Scleral Buckling

Keywords

eyepneumatic retinopexytopical

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants With Return of Intraocular Pressure to Normal Levels

    Month 2

Study Arms (2)

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.

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.

Drug: Timolol-dorzolamide (Glaucoma drops)Drug: standard post-operative topical drops

Interventions

Timolol-dorzolamide (Glaucoma drops)DRUG

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.

Also known as: timol, glaucoma drops, dorzolamide, timol-dorzolamide
Post surgery with glaucoma drops
standard post-operative topical dropsDRUG

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

Also known as: glaucoma, drops, standard of care, oral, corticosteroid, prednisolone, Polymyxin B, trimethoprim
Post surgery with glaucoma dropsPost surgery without glaucoma drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

dorzolamide-timolol combinationdorzolamideStandard of CareAdrenal Cortex HormonesPrednisolonePolymyxin BTrimethoprim

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPolymyxinsPeptides, CyclicMacrocyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteinsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Jason Hsu, MD
Organization
Mid Atlantic Retina
research@midatlanticretina.com
215-928-3092

Study Officials

  • Jason Hsu, MD

    Wills Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

April 18, 2013

First Posted

May 1, 2013

Study Start

June 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 30, 2018

Results First Posted

February 6, 2017

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)