A Comparison Between Deep Sclerectomy and Trabeculectomy

NCT ID: NCT00595855

Last Updated: 2008-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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:

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

study visits: every 4 months

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TE

trabeculectomy

Group Type ACTIVE_COMPARATOR

trabeculectomy

Intervention Type PROCEDURE

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

DS

deep sclerectomy

Group Type EXPERIMENTAL

deep sclerectomy

Intervention Type PROCEDURE

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

Interventions

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trabeculectomy

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

Intervention Type PROCEDURE

deep sclerectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Parma

OTHER

Sponsor Role lead

Responsible Party

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UNIVERSITY OF PARMA

Principal Investigators

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Gandolfi Stefano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Parma

Locations

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Sally Williams

Parma, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PARMASURG001

Identifier Type: -

Identifier Source: org_study_id

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