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OpenTrials
Completed

NCT Number: NCT00695747

Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy

The purpose of this study is to compare the safety & effectiveness of the two types of cataract and glaucoma surgeries. Results from this study may improve the surgical and post surgical management and long term management of patients with these conditions in the future

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

About this study

The purpose of this study is to determine whether a Two-Site Technique for the Combined Procedure for subjects with coexisting visually significant glaucoma & cataracts will result in an improvement in IOP control in both the immediate and longer term postoperative period as compared with the currently Standard One Site surgical technique for both glaucoma and cataracts.

Research and data indicate that the success rate of the glaucoma part of this operation may be improved if the incision for the cataract part of the operation is separated from the drainage hole created for the glaucoma part, the constant drainage through this hole is what lowers the intraocular pressure after surgery. Using the Two-Site Combined procedure the glaucoma incision(drainage hole) will still be created superiorly, under the upper lid. The cataract incision will be moved to the temporal side of the eye ball, away from the drainage hole for the glaucoma.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Meet the current criteria for combined procedure surgery:
  • A visually significant cataract(ie: an opacification of the crystalline lens resulting in a reduction of visual performance affecting daily living
  • Open angle or mixed mechanism glaucoma inadequately controlled on current therapy, or requiring two or more medications for control, or with advanced visual field and optic nerve damage.

Exclusion criteria

  • Subjects with normal tension glaucoma(defined as those subjects in whom no IOPs greater than 21 mm Hg[preceding or during therapy]have been recorded)
  • Subjects with uveitis
  • Subjects with neovascular glaucoma
  • Severe conjunctival inflammation or scarring
  • Subjects who have had previous incisional ocular surgery in the same eye
  • No subjects will have second eye operated on within 8 weeks of the first eye

Treatment and study plan

2 Site procedure- Phacoemulsification/IOL and Trabeculectomy

Procedure

2 Site Combined Procedure: in which a temporal clear cornea approach would be used for the cataract/IOL part of the procedure, and immediately thereafter the superior limbus would be employed for a limbus-based trabeculectomy

Other names: Coexisting Cataract and glaucoma, Cateract, Glaucoma, Phacoemulsification/IOL, Trabeculectomy

Primary outcomes

  1. Post-Op outcomes of IOP less than or equal to 16mm Hg without additional ocular hypotensive medications

    Time frame: Assessments made at 3 months post op, 3 month intervals for at least 2 years post surgery

Sponsors and collaborators

Lead sponsor

Lahey Clinic

Other

Registry information

Important dates

Study start
1998
Primary completion
2009
Study completion
2009
First posted
Jun 12, 2008
Registry last updated
Jan 22, 2009

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.

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