A Comparison Between Deep Sclerectomy and Trabeculectomy

January 7, 2008 updated by: University of Parma

Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  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

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Parma, Italy, 43100
        • Sally Williams

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TE
trabeculectomy
Procedure: trabeculectomy
Cairns-like trabeculectomy, limbus based, with 5_FU supplementation and argon laser suturelysis
Experimental: DS
deep sclerectomy
Procedure: deep sclerectomy
deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Parma

Investigators

  • Principal Investigator: Gandolfi Stefano, MD, University of Parma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

January 16, 2008

Last Update Submitted That Met QC Criteria

January 7, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARMASURG001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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