A Comparison Between Deep Sclerectomy and Trabeculectomy - Full Text View

Sponsored by:	University of Parma
Information provided by:	University of Parma
ClinicalTrials.gov Identifier:	NCT00595855

Purpose

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.

Condition	Intervention
Glaucoma	Procedure: trabeculectomy Procedure: deep sclerectomy

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial

Further study details as provided by University of Parma:

Primary Outcome Measures:

intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits) [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

(a) LogMAR visual acuity, (b) number of cataract extraction procedures [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Enrollment:	70
Study Start Date:	October 1997
Study Completion Date:	December 2006
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
TE: Active Comparator trabeculectomy	Procedure: trabeculectomy Cairns-like trabeculectomy, limbus based, with 5_FU supplementation and argon laser suturelysis
DS: Experimental deep sclerectomy	Procedure: deep sclerectomy deep sclerectomy with no implant and no sutures to the superficial flap, limbus based with suppplementation of FU (if needed)

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:

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

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595855

Locations

Italy
Sally Williams
parma, Italy, 43100

Sponsors and Collaborators

University of Parma

Investigators

Principal Investigator:

Gandolfi Stefano, MD

university of Parma, Italy

More Information

Responsible Party:	UNIVERSITY OF PARMA ( STEFANO GANDOLFI, CHAIRMAN UNIV. EYE CLINIC )
Study ID Numbers:	PARMASURG001
Study First Received:	January 7, 2008
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00595855
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Parma:

glaucoma
surgery
non penetrating procedures
cataract

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Cataract
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009