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OpenTrials
Completed

NCT Number: NCT01228799

Trabeculectomy Versus Canaloplasty

Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.

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Key information

Conditions

Glaucoma Canaloplasty Eye Diseases Ocular Hypertension Trabeculectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Eye Hospital

Würzburg, Bavaria, 97080, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1. diagnosed primary or secondary open-angle glaucoma 2. IOP > 16 mmHg (<60 days prior surgery) 3. IOP > 21 mmHg 4. no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed

Exclusion criteria

  • angle closure glaucoma
  • congenital glaucoma
  • combined procedures (glaucoma and cataract)

Treatment and study plan

trabeculectomy

Procedure

trabeculectomy with mitomycin C 0.2mg/ml

Canaloplasty

Procedure

Canaloplasty with implant of suture

Primary outcomes

  1. success rate (complete and qualified success)

    Time frame: 1 year

    Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg

  2. success rate (complete and qualified success)

    Time frame: 2 years

    Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg

Secondary outcomes

  1. IOP, medication, complications

    Time frame: 1 year

    intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively

  2. IOP, medication, complications

    Time frame: 2 years

    intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively

Sponsors and collaborators

Lead sponsor

University Eye Hospital, Würzburg

Other

Registry information

Official study title

Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma

Acronym: TVC

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 27, 2010
Registry last updated
Aug 19, 2013

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.

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