A Comparison Between Deep Sclerectomy and Trabeculectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00595855

Enrollment

Registered

2008-01-16

Start date

1997-10-31

Completion date

2006-12-31

Last updated

2008-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

glaucoma, surgery, non penetrating procedures, cataract

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: 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

Interventions

PROCEDUREtrabeculectomy

Cairns-like trabeculectomy, limbus based, with 5\_FU supplementation and argon laser suturelysis

PROCEDUREdeep sclerectomy

deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)	7 years

Secondary

Measure	Time frame
(a) LogMAR visual acuity, (b) number of cataract extraction procedures	7 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026