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A Comparison Between Deep Sclerectomy and Trabeculectomy

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. Identifier: NCT00595855
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : January 16, 2008
Information provided by:
University of Parma

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.

Condition or disease Intervention/treatment Phase
Glaucoma Procedure: trabeculectomy Procedure: deep sclerectomy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
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
Study Start Date : October 1997
Actual Primary Completion Date : January 2007
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: TE
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)

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00595855

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Sally Williams
Parma, Italy, 43100
Sponsors and Collaborators
University of Parma
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Principal Investigator: Gandolfi Stefano, MD University of Parma
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Other Study ID Numbers: PARMASURG001
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008
Keywords provided by University of Parma:
non penetrating procedures
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases