A Comparison Between Deep Sclerectomy and Trabeculectomy | NCT00595855

Studies
A Comparison Between Deep Sclerectomy and Trabeculectomy

NCT00595855

Sponsor

University of Parma

Status

Completed

Last Update Posted

Jan 16, 2008Estimated

Enrollment

70Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

trabeculectomy
deep sclerectomy

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1997

Primary Completion Date

Jan 2007Actual

Completion Date

Dec 2006Actual

First Submitted Date

Jan 7, 2008

First Submission Date that Met QC Criteria

Jan 7, 2008

First Posted Date

Jan 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2008

Last Update Posted Date

Jan 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Prospective 7-year randomised investigator -masked clinical trial 79 eyes (79 patients) enrolled randomised to surgery by PEX and previous pilocarpine use Deep sclerectomy n = 41 Trabeculectomy n = 38 Estimated DS : TE success = 1:3 10% attrition ; power = 90%, alpha = 5%

Methods and evaluation of outcomes:

IOP: average of the two highest readings of the IOP phasing (6 readings)
VA: LogMAR (ETDRS chart)
Lens: LOCSII (slit lamp classification), worsening = one step progression confirmed at two visits

study visits: every 4 months

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TE	Active Comparator	trabeculectomy	Procedure: trabeculectomy
DS	Experimental	deep sclerectomy	Procedure: deep sclerectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
trabeculectomy	Procedure	Cairns-like trabeculectomy, limbus based, with 5_FU supplementation and argon laser suturelysis	TE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)		7 years

Secondary Outcomes

Measure	Description	Time Frame
(a) LogMAR visual acuity, (b) number of cataract extraction procedures		7 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gandolfi Stefano, MD	University of Parma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sally Williams		Parma		43100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma
D002386	Cataract

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases
D007905	Lens Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014130	Trabeculectomy

Ancestor Terms

ID	Term
D018463	Filtering Surgery
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided