NCT00595855

Brief Summary

Patients affected by medically uncontrolled open angle glaucoma will be randomised to either a non penetrating procedure (deep sclerectomy) or conventional trabeculectomy. The longterm efficacy (i.e. IOP w/out therapy) and safety (i.e. visual acuity, visual field stability and co-morbidities) will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 1997

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
9.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
Last Updated

January 16, 2008

Status Verified

January 1, 2008

Enrollment Period

9.3 years

First QC Date

January 7, 2008

Last Update Submit

January 7, 2008

Conditions

Glaucoma

Keywords

glaucomasurgerynon penetrating procedurescataract

Outcome Measures

Primary Outcomes (1)

  • intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)

    7 years

Secondary Outcomes (1)

  • (a) LogMAR visual acuity, (b) number of cataract extraction procedures

    7 years

Study Arms (2)

TE

ACTIVE COMPARATOR

trabeculectomy

Procedure: trabeculectomy

DS

EXPERIMENTAL

deep sclerectomy

Procedure: deep sclerectomy

Interventions

trabeculectomyPROCEDURE

Cairns-like trabeculectomy, limbus based, with 5\_FU supplementation and argon laser suturelysis

TE
deep sclerectomyPROCEDURE

deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)

DS

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Angle wide open
  • Age \> 65 yrs
  • IOP \> 23 and \< 30 mmHg (average of the two highest readings of the daily IOP phasing)
  • Topical beta blocker in fellow eye
  • At least two medications in use + previous ALT
  • MD \< 20 dB (HFA 24-2 full threshold)
  • LOCSII \< C1-N1-P0

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sally Williams

Parma, 43100, Italy

Location

MeSH Terms

Conditions

GlaucomaCataract

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Gandolfi Stefano, MD

    University of Parma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

October 1, 1997

Primary Completion

January 1, 2007

Study Completion

December 1, 2006

Last Updated

January 16, 2008

Record last verified: 2008-01

Locations

IT(1)