Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy - Full Text View

Sponsored by:	Lahey Clinic
Information provided by:	Lahey Clinic
ClinicalTrials.gov Identifier:	NCT00695747

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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy

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
1: No Intervention Standard 1 site Procedure using a fornix based incision, performed superiorly
2: Experimental 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

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

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:

Palmer SS. Mitomycin as adjunct chemotherapy with trabeculectomy. Ophthalmology. 1991 Mar;98(3):317-21.

Shingleton BJ, Jacobson LM, Kuperwaser MC. Comparison of combined cataract and glaucoma surgery using planned extracapsular and phacoemulsification techniques. Ophthalmic Surg Lasers. 1995 Sep-Oct;26(5):414-9.

Gandolfi SA, Vecchi M. 5-fluorouracil in combined trabeculectomy and clear-cornea phacoemulsification with posterior chamber intraocular lens implantation. A one-year randomized, controlled clinical trial. Ophthalmology. 1997 Feb;104(2):181-6.

Shin DH, Simone PA, Song MS, Reed SY, Juzych MS, Kim C, Hughes BA. Adjunctive subconjunctival mitomycin C in glaucoma triple procedure. Ophthalmology. 1995 Oct;102(10):1550-8.

Joos KM, Bueche MJ, Palmberg PF, Feuer WJ, Grajewski AL. One-year follow-up results of combined mitomycin C trabeculectomy and extracapsular cataract extraction. Ophthalmology. 1995 Jan;102(1):76-83.

Berestka JS, Brown SV. Limbus- versus fornix-based conjunctival flaps in combined phacoemulsification and mitomycin C trabeculectomy surgery. Ophthalmology. 1997 Feb;104(2):187-96.

Scott IU, Greenfield DS, Schiffman J, Nicolela MT, Rueda JC, Tsai JC, Palmberg PF. Outcomes of primary trabeculectomy with the use of adjunctive mitomycin. Arch Ophthalmol. 1998 Mar;116(3):286-91.

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

Keywords provided by Lahey Clinic:

Glaucoma
Cataracts
Phacoemulsification(IOL)
Trabeculectomy

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Cataract

Lens Diseases
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on February 12, 2009