NCT01887223

Brief Summary

When the glaucoma filtering surgery failures (intraocular pressure rises again), the options is start to use the hypotensive eye drops again (medical treatment). However, in some cases (encapsulated blebs), there is a simple surgical revision that can revival the primary failure surgery. It calls transconjunctival needling revision. In this study, the investigators compare the efficacy of this revision versus medical treatment in 12-month follow up in eyes with encapsulated blebs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

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

May 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

1.1 years

First QC Date

June 24, 2013

Last Update Submit

June 26, 2013

Conditions

Primary Open Angle Glaucoma

Keywords

Encapsulated blebstrabeculectomy failureglaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure

    12 months

Study Arms (2)

Transconjunctival needling revision

EXPERIMENTAL

Eyes with primary glaucoma surgery failure with encapsulated bleb submitted to surgical revision

Procedure: Transconjunctival needling revision

Medical treatment

ACTIVE COMPARATOR

Eyes with primary glaucoma surgery failure with encapsulated blebs were treated with medical treatment (hypotensive eye drops)

Drug: Medical treatment

Interventions

Transconjunctival needling revisionPROCEDURE

Surgical revision. A 25 Gauge needle was inserted under the subconjunctival space and perforate the encapsulated bled. The encapsulated bleb was ruptured with sweeping movement up and down, back and forth.

Transconjunctival needling revision
Medical treatmentDRUG

Hypotensive eye drops are initialized one by one regarding intraocular pressure control. Nonspecific beta blocker and/or prostaglandin, followed by carbonic anhydrase inhibitors and/or selective alpha agonist.

Also known as: Timoptol 0,5%, Xalatan, Trusopt, Alphagan
Medical treatment

Eligibility Criteria

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

You may qualify if:

  • Eyes with encapsulated blebs developed in 5 months or less following primary glaucoma filtering surgery (trabeculectomy) and intraocular pressure \>= 20mmHg

You may not qualify if:

  • Previous other ocular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

  • Costa VP, Correa MM, Kara-Jose N. Needling versus medical treatment in encapsulated blebs. A randomized, prospective study. Ophthalmology. 1997 Aug;104(8):1215-20. doi: 10.1016/s0161-6420(97)30155-9.

    PMID: 9261306RESULT

  • Suzuki R, Susanna R Jr. Early transconjunctival needling revision with 5-fluorouracil versus medical treatment in encapsulated blebs: a 12-month prospective study. Clinics (Sao Paulo). 2013 Oct;68(10):1376-9. doi: 10.6061/clinics/2013(10)14.

    PMID: 24212847DERIVED

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Interventions

LatanoprostdorzolamideBrimonidine Tartrate

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsQuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Remo Susanna Jr., MD

    University of Sao Paulo General Hospital

    STUDY CHAIR

  • Ricardo Suzuki, MD

    University of Sao Paulo General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Ophthalmology at HCFMUSP

Study Record Dates

First Submitted

June 24, 2013

First Posted

June 26, 2013

Study Start

May 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

BR(1)