Skip to main content
OpenTrials
Completed

NCT Number: NCT00595855

A Comparison Between Deep Sclerectomy and Trabeculectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma Cataract Eye Diseases Lens Diseases Ocular Hypertension

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sally Williams

Parma, 43100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

trabeculectomy

Procedure

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

deep sclerectomy

Procedure

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

Primary outcomes

  1. intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)

    Time frame: 7 years

Secondary outcomes

  1. (a) LogMAR visual acuity, (b) number of cataract extraction procedures

    Time frame: 7 years

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2007
Study completion
2006
First posted
Jan 16, 2008
Registry last updated
Jan 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.