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

NCT00695747 | Completed

• 1 other identifier: 98-067
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma; Cataracts

Keywords

Glaucoma; Cataracts; Phacoemulsification(IOL); Trabeculectomy

Outcome Measures

Primary Outcomes (1)

• Post-Op outcomes of IOP less than or equal to 16mm Hg without additional ocular hypotensive medications

  Assessments made at 3 months post op, 3 month intervals for at least 2 years post surgery

Study Arms (2)

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

Interventions

2 Site procedure- Phacoemulsification/IOL and Trabeculectomy PROCEDURE

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

Also known as: Coexisting Cataract and glaucoma, Cateract, Glaucoma, Phacoemulsification/IOL, Trabeculectomy

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Related Publications (8)

• Palmer SS. Mitomycin as adjunct chemotherapy with trabeculectomy. Ophthalmology. 1991 Mar;98(3):317-21. doi: 10.1016/s0161-6420(91)32293-0.

  PMID: 2023752 BACKGROUND

• 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.

  PMID: 8963855 BACKGROUND

• 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.

  PMID: 9052620 BACKGROUND

• 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.

  PMID: 9097805 BACKGROUND

• 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.

  PMID: 7831046 BACKGROUND

• 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.

  PMID: 9052621 BACKGROUND

• 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.

  PMID: 9514480 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Glaucoma; Cataract

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Paul R. Cotran, M.D.

  Lahey Clinic, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 12, 2008
• Study Start: January 1, 1998
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: January 22, 2009

Record last verified: 2009-01

Locations

US (1)