Intraocular Pressure Control Following One Site Versus Two Site Combined Phacoemulsification/IOL And Trabeculectomy
NCT ID: NCT00695747
Last Updated: 2009-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
1998-01-31
2009-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Standard 1 site Procedure using a fornix based incision, performed superiorly
No interventions assigned to this group
2
2 Site Combined 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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
No
Sponsors
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Lahey Clinic
OTHER
Responsible Party
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Lahey Clinic, Inc.
Principal Investigators
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Paul R. Cotran, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lahey Clinic, Inc.
Locations
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Lahey Clinic, Inc.
Burlington, Massachusetts, United States
Countries
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References
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Palmer SS. Mitomycin as adjunct chemotherapy with trabeculectomy. Ophthalmology. 1991 Mar;98(3):317-21. doi: 10.1016/s0161-6420(91)32293-0.
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. doi: 10.1016/s0161-6420(97)30336-4.
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. doi: 10.1016/s0161-6420(95)30832-9.
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. doi: 10.1016/s0161-6420(95)31050-0.
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. doi: 10.1016/s0161-6420(97)30335-2.
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. doi: 10.1001/archopht.116.3.286.
Parrish RK II, Folberg R. Wound healing in glaucoma surgery: In: Ritch R. Shields MB, Krupin T, eds. The Glaucomas 2nd ed. St. Louis: CV Mosby 1989, vol III, chap. 81
Other Identifiers
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98-067
Identifier Type: -
Identifier Source: org_study_id
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