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Completed

NCT Number: NCT00444080

Comparison of Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for which filtering surgery is indicated. Surgical success was defined as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further glaucoma surgery. Postoperative intraocular pressure, number of medications, complications and success rates were followed for 2 years.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osler Eyecare, Mississauga, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult subject over the age of 18
  • Subject diagnosed with open angle glaucoma (POAG, PXFG or PDSG) or ocular hypertension
  • Subject is a candidate for filtering surgery with intraoperative anti-metabolites
  • IOP > 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit.
  • Subject willing to attend all follow-up evaluations
  • Subject willing to sign informed consent.

Exclusion criteria

  • Subject diagnosed with: PACG, NTG, secondary glaucoma, neovascular glaucoma
  • Subject has history of glaucoma surgery (filtering, glaucoma drainage device, cyclo destructive procedures)
  • Subject has history of penetrating keratoplasty (PKP)
  • Subject underwent large incision extra capsular cataract extraction
  • Subject had cataract phacoemulsification within the last month
  • Subject has a visually significant cataract that is planned for extraction at the time of filtering surgery or within 12 months thereafter
  • Any ocular disease or history in the operated eye other than glaucoma and cataract, such as uveitis, ocular infection, severe dry eye, severe blepharitis , active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, aphakia, and ocular pathology that may interfere with accurate IOP measurements
  • Subject has vitreous present in the anterior chamber for which vitrectomy is anticipated
  • IOP of ≤18mmHg
  • Subject participates in any other concurrent ocular investigation.

Treatment and study plan

trabeculectomy

Procedure

Standard trabeculectomy procedure

  • Creation of a fornix or limbal based conjunctival flap in upper quadrants
  • Creation of a limbal-based scleral flap extending into clear cornea
  • Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
  • Creation of fistula 1mm x 2mm in size
  • Iridectomy
  • Suturing the scleral flap
  • Repositioning of conjunctiva with sutures After procedure, antibiotics & steroids are administered topically; eye is covered with a pad - patient is discharged.

Ex-PRESS mini shunt

Device

Ex-PRESS implantation procedure:

  • Creation of a fornix or limbal based conjunctival flap in upper quadrants
  • Creation of limbal-based scleral flap extending into clear cornea
  • Delicate application of MMC solution onto sclerectomy bed. (MMC concentration 0.4mg/ml for 1-3 minutes)
  • Penetration into anterior chamber using 23-25G needle, halfway between the white sclera and clear cornea (in the center of the grey zone);creation of track incision at limbus
  • Prior to implantation, a thorough mobility check should be performed
  • Implantation of Ex-PRESS implant loaded on its introducer, through that pre-incision
  • Withdrawal of introducer
  • Tucking plate under the scleral flap, and verification of its position
  • Suturing scleral flap After implantation procedure, antibiotics & steroids administered topically; eye is covered with a pad - patient is discharged.

Primary outcomes

  1. Postoperative Intraocular Pressure

    Time frame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported

    Mean postoperative intraocular pressure

  2. Medications

    Time frame: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported

Secondary outcomes

  1. Safety - Incidence of Adverse Events

    Time frame: 24 months

    Comparison of the incidence of all adverse events that occur during the intra-operative and postoperative periods between the two study arms. More than 1 complication may have occurred in the same subject.

  2. Efficacy - The Number of Participants With Qualified and Complete Success

    Time frame: 24 months

    The secondary effectiveness measure will be qualified and complete success rate defined as IOP≤18mmHg with or without medications in the test group as compared to qualified and complete success rate in the concurrent control group at 24 month

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2007
Registry last updated
Oct 14, 2020

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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