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

January 21, 2009 updated by: Lahey Clinic
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Standard 1 site Procedure using a fornix based incision, performed superiorly
Experimental: 2
2 Site Combined Procedure
Procedure: 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy
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:
  • Trabeculectomy
  • Coexisting Cataract and glaucoma
  • Cateract
  • Glaucoma
  • Phacoemulsification/IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessments made at 3 months post op, 3 month intervals for at least 2 years post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahey Clinic

Investigators

  • Principal Investigator: Paul R. Cotran, M.D., Lahey Clinic, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 10, 2008

First Submitted That Met QC Criteria

June 10, 2008

First Posted (Estimate)

June 12, 2008

Study Record Updates

Last Update Posted (Estimate)

January 22, 2009

Last Update Submitted That Met QC Criteria

January 21, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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