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

This study has been completed.
Sponsor:
Information provided by:
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00695747
First received: June 10, 2008
Last updated: January 21, 2009
Last verified: January 2009
  Purpose

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


Condition Intervention
Glaucoma
Cataracts
Procedure: 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy

Resource links provided by NLM:


Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 95
Study Start Date: January 1998
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Coexisting Cataract and glaucoma
  • Cateract
  • Glaucoma
  • Phacoemulsification/IOL
  • Trabeculectomy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695747

Locations
United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Paul R. Cotran, M.D. Lahey Clinic, Inc.
  More Information

Publications:
Responsible Party: Paul R. Cotran, M.D., Lahey Clinic, Inc.
ClinicalTrials.gov Identifier: NCT00695747     History of Changes
Other Study ID Numbers: 98-067
Study First Received: June 10, 2008
Last Updated: January 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Glaucoma
Cataracts
Phacoemulsification(IOL)
Trabeculectomy

Additional relevant MeSH terms:
Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on August 28, 2014