NCT01257698

Brief Summary

The purpose of this study is to see if glaucoma eye drops (dorzolamide-timolol) have any effect on the duration of an intraocular gas bubble following pars plana vitrectomy.

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 Feb 2010

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

September 4, 2019

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

3.3 years

First QC Date

December 8, 2010

Results QC Date

September 16, 2018

Last Update Submit

August 13, 2019

Conditions

Macular HoleRetinal Detachment

Keywords

VitrectomyGas bubbleRetinal detachmentMacular holeAqueous suppressant

Outcome Measures

Primary Outcomes (1)

  • Duration of Intraocular Gas

    Patients will self-monitor gas bubble duration and will receive weekly phone calls by the study coordinator until gas disappearance is confirmed.

    Up to 4 weeks

Study Arms (2)

Dorzolamide-timolol topical drops

ACTIVE COMPARATOR
Drug: Dorzolamide 2%-timolol 0.5% topical eyedrops

Standard of care

NO INTERVENTION

Interventions

Dorzolamide 2%-timolol 0.5% topical eyedropsDRUG

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.

Also known as: Cosopt
Dorzolamide-timolol topical drops

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for pars plana vitrectomy with intraocular gas tamponade with sulfur hexafluoride (e.g., retinal detachment, macular hole, other condition at the discretion of the investigator).
  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.

You may not qualify if:

  • Prior trabeculectomy or tube shunt surgery.
  • Current use of topical aqueous suppressants or other glaucoma medications.
  • Aphakia or presence of anterior chamber intraocular lens implant.
  • Known allergy or contraindication to sulfa or beta-blocker use (e.g., asthma, chronic obstructive pulmonary disease, bradycardia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (4)

  • Lee MS, Pasha M, Weitzman M. The effect of aqueous humor suppressants on intravitreal gas bubble duration in rabbits. Am J Ophthalmol. 1998 May;125(5):701-2. doi: 10.1016/s0002-9394(98)00006-3.

    PMID: 9625556BACKGROUND

  • Mittra RA, Pollack JS, Dev S, Han DP, Mieler WF, Pulido JS, Connor TB. The use of topical aqueous suppressants in the prevention of postoperative intraocular pressure elevation after pars plana vitrectomy with long-acting gas tamponade. Ophthalmology. 2000 Mar;107(3):588-92. doi: 10.1016/s0161-6420(99)00083-4.

    PMID: 10711900BACKGROUND

  • Benz MS, Escalona-Benz EM, Murray TG, Eifrig CW, Yoder DM, Moore JK, Schiffman JC. Immediate postoperative use of a topical agent to prevent intraocular pressure elevation after pars plana vitrectomy with gas tamponade. Arch Ophthalmol. 2004 May;122(5):705-9. doi: 10.1001/archopht.122.5.705.

    PMID: 15136318BACKGROUND

  • Shah CP, Hsu J, Spirn MJ, Donoso L, Garg SJ. Topical aqueous suppression does not significantly affect duration of intraocular gas tamponade after vitrectomy. Retina. 2012 Jan;32(1):168-71. doi: 10.1097/IAE.0b013e31822092a4.

    PMID: 21878847RESULT

MeSH Terms

Conditions

Retinal PerforationsRetinal Detachment

Interventions

dorzolamideTimololOphthalmic Solutionsdorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

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

Study Officials

  • Jason Hsu, MD

    Mid Atlantic Retina

    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
PRINCIPAL INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 10, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 4, 2019

Results First Posted

September 4, 2019

Record last verified: 2019-08

Locations

US(1)