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A Comparison Between Deep Sclerectomy and Trabeculectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00595855
First Posted: January 16, 2008
Last Update Posted: January 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Parma
  Purpose
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.

Condition Intervention
Glaucoma Procedure: trabeculectomy Procedure: deep sclerectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Parma:

Primary Outcome Measures:
  • intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits) [ Time Frame: 7 years ]

Secondary Outcome Measures:
  • (a) LogMAR visual acuity, (b) number of cataract extraction procedures [ Time Frame: 7 years ]

Enrollment: 70
Study Start Date: October 1997
Study Completion Date: December 2006
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595855


Locations
Italy
Sally Williams
Parma, Italy, 43100
Sponsors and Collaborators
University of Parma
Investigators
Principal Investigator: Gandolfi Stefano, MD University of Parma
  More Information

Responsible Party: STEFANO GANDOLFI, CHAIRMAN UNIV. EYE CLINIC, UNIVERSITY OF PARMA
ClinicalTrials.gov Identifier: NCT00595855     History of Changes
Other Study ID Numbers: PARMASURG001
First Submitted: January 7, 2008
First Posted: January 16, 2008
Last Update Posted: January 16, 2008
Last Verified: January 2008

Keywords provided by University of Parma:
glaucoma
surgery
non penetrating procedures
cataract

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases