Back to resultsA Comparison Between Deep Sclerectomy and Trabeculectomy
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
trabeculectomy
deep sclerectomy
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, surgery, non penetrating procedures, cataract
Eligibility 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
Sites / Locations
- Sally Williams
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TE
DS
Arm Description
trabeculectomy
deep sclerectomy
Outcomes
Primary Outcome Measures
intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)
Secondary Outcome Measures
(a) LogMAR visual acuity, (b) number of cataract extraction procedures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00595855
Brief Title
A Comparison Between Deep Sclerectomy and Trabeculectomy
Official Title
Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Parma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
IOP: average of the two highest readings of the IOP phasing (6 readings)
VA: LogMAR (ETDRS chart)
Lens: LOCSII (slit lamp classification), worsening = one step progression confirmed at two visits
study visits: every 4 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, surgery, non penetrating procedures, cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TE
Arm Type
Active Comparator
Arm Description
trabeculectomy
Arm Title
DS
Arm Type
Experimental
Arm Description
deep sclerectomy
Intervention Type
Procedure
Intervention Name(s)
trabeculectomy
Intervention Description
Cairns-like trabeculectomy, limbus based, with 5_FU supplementation and argon laser suturelysis
Intervention Type
Procedure
Intervention Name(s)
deep sclerectomy
Intervention Description
deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)
Primary Outcome Measure Information:
Title
intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)
Time Frame
7 years
Secondary Outcome Measure Information:
Title
(a) LogMAR visual acuity, (b) number of cataract extraction procedures
Time Frame
7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gandolfi Stefano, MD
Organizational Affiliation
University of Parma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sally Williams
City
Parma
ZIP/Postal Code
43100
Country
Italy
12. IPD Sharing Statement
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A Comparison Between Deep Sclerectomy and Trabeculectomy
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