A Comparison Between Deep Sclerectomy and Trabeculectomy

Glaucoma Clinical Trial

Official title:

Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595855
• Other study ID #: PARMASURG001
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: January 7, 2008
• Start date: October 1997
• Est. completion date: December 2006

Study information

• Verified date: January 2008
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2006
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Italy	Sally Williams	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)		7 years	No
Secondary	(a) LogMAR visual acuity, (b) number of cataract extraction procedures		7 years	Yes