A Comparison Between Deep Sclerectomy and Trabeculectomy

University of Parma

Status: Completed

Conditions: Glaucoma

Treatments: Procedure: deep sclerectomy; Procedure: trabeculectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00595855

PARMASURG001

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

TE

Active Comparator group

Description:

trabeculectomy

Treatment:

Procedure: trabeculectomy

DS

Experimental group

Description:

deep sclerectomy

Treatment:

Procedure: deep sclerectomy