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

Primary Purpose

Glaucoma, Cataracts

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

2 Site procedure- Phacoemulsification/IOL and Trabeculectomy

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Cataracts, Phacoemulsification(IOL), Trabeculectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lahey Clinic, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm Description

Standard 1 site Procedure using a fornix based incision, performed superiorly

2 Site Combined Procedure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00695747

First Posted

June 10, 2008

Last Updated

January 21, 2009

Sponsor

Lahey Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00695747

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

January 1998 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Lahey Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Cataracts

Keywords

Glaucoma, Cataracts, Phacoemulsification(IOL), Trabeculectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

95 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

No Intervention

Arm Description

Standard 1 site Procedure using a fornix based incision, performed superiorly

Arm Title

Arm Type

Experimental

Arm Description

2 Site Combined Procedure

Intervention Type

Procedure

Intervention Name(s)

2 Site procedure- Phacoemulsification/IOL and Trabeculectomy

Other Intervention Name(s)

Coexisting Cataract and glaucoma, Cateract, Glaucoma, Phacoemulsification/IOL, Trabeculectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul R. Cotran, M.D.

Organizational Affiliation

Lahey Clinic, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lahey Clinic, Inc.

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

2023752

Citation

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

Results Reference

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PubMed Identifier

8963855

Citation

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.

Results Reference

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PubMed Identifier

9052620

Citation

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.

Results Reference

background

PubMed Identifier

9097805

Citation

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.

Results Reference

background

PubMed Identifier

7831046

Citation

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.

Results Reference

background

PubMed Identifier

9052621

Citation

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.

Results Reference

background

PubMed Identifier

9514480

Citation

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.

Results Reference

background

Citation

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

Results Reference

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

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