A Comparison Between Deep Sclerectomy and Trabeculectomy

This study has been completed.
Sponsor:
Information provided by:
University of Parma
ClinicalTrials.gov Identifier:
NCT00595855
First received: January 7, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00595855

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

No publications provided

Responsible Party: STEFANO GANDOLFI, CHAIRMAN UNIV. EYE CLINIC, UNIVERSITY OF PARMA
ClinicalTrials.gov Identifier: NCT00595855     History of Changes
Other Study ID Numbers: PARMASURG001
Study First Received: January 7, 2008
Last Updated: January 7, 2008
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014