A Comparison Between Deep Sclerectomy and Trabeculectomy
NCT ID: NCT00595855
Last Updated: 2008-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
1997-10-31
2006-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TE
trabeculectomy
trabeculectomy
Cairns-like trabeculectomy, limbus based, with 5\_FU supplementation and argon laser suturelysis
DS
deep sclerectomy
deep sclerectomy
deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)
Interventions
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trabeculectomy
Cairns-like trabeculectomy, limbus based, with 5\_FU supplementation and argon laser suturelysis
deep sclerectomy
deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)
Eligibility Criteria
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Inclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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University of Parma
OTHER
Responsible Party
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UNIVERSITY OF PARMA
Principal Investigators
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Gandolfi Stefano, MD
Role: PRINCIPAL_INVESTIGATOR
University of Parma
Locations
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Sally Williams
Parma, , Italy
Countries
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Other Identifiers
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PARMASURG001
Identifier Type: -
Identifier Source: org_study_id
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