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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00695747
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : January 22, 2009
Information provided by:
Lahey Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Cataracts Procedure: 2 Site procedure- Phacoemulsification/IOL and Trabeculectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy
Study Start Date : January 1998
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

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:
  • Coexisting Cataract and glaucoma
  • Cateract
  • Glaucoma
  • Phacoemulsification/IOL
  • Trabeculectomy

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00695747

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

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Responsible Party: Paul R. Cotran, M.D., Lahey Clinic, Inc. Identifier: NCT00695747    
Other Study ID Numbers: 98-067
First Posted: June 12, 2008    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009
Keywords provided by Lahey Clinic:
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Lens Diseases