Re-Trabeculectomy Versus Ahmed Glaucoma Valve Implantation in Secondary Surgical Management of Patients With Refractory Glaucoma

Refractory Primary Open Angle Glaucoma Clinical Trial

Official title:

Re-Trabeculectomy Versus Ahmed Glaucoma Valve Implantation in Secondary Surgical Management of Patients With Refractory Primary Open Angle Glaucoma: a Three-year Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633775
• Other study ID #: VESC#2007-056
• Status: Completed
• Phase: N/A
• First received: June 29, 2012
• Last updated: July 3, 2012
• Start date: December 2007
• Est. completion date: January 2012

Study information

• Verified date: June 2012
• Source: Vanak Eye Surgery Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to compare three-year outcomes of re-trabeculectomy with those of Ahmed glaucoma valve implantation in secondary surgical management of patients with primary open angle glaucoma (POAG) and a history of previous failed trabeculectomy.

Description:

Currently, lowering intraocular pressure (IOP) is the only treatment modality to prevent or slow progression of glaucomatous optic nerve damage. Incisional procedures are indicated when medical therapy and/or laser procedures cannot adequately reduce IOP. Trabeculectomy is the most common glaucoma incisional procedure globally. On the other hand, glaucoma drainage devices that have been historically reserved for cases of glaucoma deemed at high risk of failure have increasingly gained popularity particularly in eyes with previous history of glaucoma surgery.

There is still no agreement on the appropriate surgical procedure in those with prior glaucoma surgery. The five-year tube versus trabeculectomy (TVT) study, which evaluated the efficacy and safety of Baerveldt glaucoma implant versus trabeculectomy, showed that both surgical procedures had similar IOP reduction and use of anti-glaucoma medication; tube shunt surgery had a higher success rate than trabeculectomy with mitomycin C (MMC); the trabeculectomy/MMC had higher incidence of early postoperative complications compared to tube shunt surgery; and rates of late postoperative complications, reoperation for complications, and cataract extraction were comparable in both treatment groups.

In this study, the investigators compared three-year outcomes of re-trabeculectomy with those of Ahmed glaucoma valve implantation in secondary surgical management of patients with primary open angle glaucoma and a previous history of failed trabeculectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Uncontrolled glaucoma defined as (1) IOP not achieving previously assigned target pressure despite prior trabeculectomy and use of maximally tolerated anti-glaucoma medication; and (2) recent progression of the disease based on glaucomatous changes in optic disc appearance and/or worsening of the visual field exam.

• In the case of two eligible eyes, only the first eye being operated on was enrolled

Exclusion Criteria:

• Younger than 40 years old

• Visual acuity of no light perception

• Lens opacity

• Elevated IOP associated with silicone oil

• Prior ocular surgeries other than one trabeculectomy with MMC

• Previous cyclodestructive treatment

• Increased risk of endophthalmitis

• Posterior segment disorders

• Pre-existing ocular comorbidities (e.g. pterygium,phacodonesis,corneal opacity, or corneal endothelial dystrophies)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Refractory Primary Open Angle Glaucoma

Intervention

Procedure:
• Implantation of Ahmed glaucoma tube shunt, and Trabeculectomy with MMC
In the Ahmed implant group, the tube shunts used were the valved 184-mm2 surface area (Model FP7; New World Medical, Inc, Rancho Cucamonga, California, USA). In the Trabeculectomy group, a routine trabeculectomy surgery was performed.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Hossein Medical Center	Tehran
Iran, Islamic Republic of	Negah Eye Hospital	Tehran
Iran, Islamic Republic of	Vanak Eye Surgery Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Vanak Eye Surgery Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (14)

Chen PP, Yamamoto T, Sawada A, Parrish RK 2nd, Kitazawa Y. Use of antifibrosis agents and glaucoma drainage devices in the American and Japanese Glaucoma Societies. J Glaucoma. 1997 Jun;6(3):192-6. — View Citation

Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC. Surgical complications in the Tube Versus Trabeculectomy Study during the first year of follow-up. Am J Ophthalmol. 2007 Jan;143(1):23-31. Epub 2006 Sep 1. — View Citation

Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC; Tube Versus Trabeculectomy Study Group. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012 May;153(5):804-814.e1. doi: 10.1016/j.ajo.2011.10.024. Epub 2012 Jan 14. — View Citation

Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL. Treatment outcomes in the tube versus trabeculectomy study after one year of follow-up. Am J Ophthalmol. 2007 Jan;143(1):9-22. Epub 2006 Sep 1. — View Citation

Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube Versus Trabeculectomy Study Group. Three-year follow-up of the tube versus trabeculectomy study. Am J Ophthalmol. 2009 Nov;148(5):670-84. doi: 10.1016/j.ajo.2009.06.018. Epub 2009 Aug 11. — View Citation

Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL; Tube versus Trabeculectomy Study Group. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012 May;153(5):789-803.e2. doi: 10.1016/j.ajo.2011.10.026. Epub 2012 Jan 15. — View Citation

Gedde SJ, Schiffman JC, Feuer WJ, Parrish RK 2nd, Heuer DK, Brandt JD; Tube Versus Trabeculectomy Study Group. The tube versus trabeculectomy study: design and baseline characteristics of study patients. Am J Ophthalmol. 2005 Aug;140(2):275-87. — View Citation

Huang MC, Netland PA, Coleman AL, Siegner SW, Moster MR, Hill RA. Intermediate-term clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1999 Jan;127(1):27-33. — View Citation

Joshi AB, Parrish RK 2nd, Feuer WF. 2002 survey of the American Glaucoma Society: practice preferences for glaucoma surgery and antifibrotic use. J Glaucoma. 2005 Apr;14(2):172-4. — View Citation

Ramulu PY, Corcoran KJ, Corcoran SL, Robin AL. Utilization of various glaucoma surgeries and procedures in Medicare beneficiaries from 1995 to 2004. Ophthalmology. 2007 Dec;114(12):2265-70. Epub 2007 Apr 27. — View Citation

Serle J, Cantor L, Gross R, Katz J, Mundorf T, Noecker R, Severin T, Simmons S, Walt J, Casciano J, Evans S, Doyle J. Best practice treatment algorithm for primary open-angle glaucoma: implications for U.S. ophthalmology practice. Manag Care Interface. 2002 Jul;15(7):37-48. — View Citation

Topouzis F, Coleman AL, Choplin N, Bethlem MM, Hill R, Yu F, Panek WC, Wilson MR. Follow-up of the original cohort with the Ahmed glaucoma valve implant. Am J Ophthalmol. 1999 Aug;128(2):198-204. — View Citation

Wilson MR, Mendis U, Paliwal A, Haynatzka V. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. Am J Ophthalmol. 2003 Sep;136(3):464-70. — View Citation

Wilson MR, Mendis U, Smith SD, Paliwal A. Ahmed glaucoma valve implant vs trabeculectomy in the surgical treatment of glaucoma: a randomized clinical trial. Am J Ophthalmol. 2000 Sep;130(3):267-73. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in target intraocular pressure (IOP)	All patients had a target IOP that had been assigned for them by the same surgeon prior to their initial failed trabeculectomy/MMC. The routine practice of the surgeon has been to set target IOP based on the Best Practice Treatment Algorithm for POAG. This was based on at least 25% reduction in baseline IOP. Target IOP needs constant reevaluation during the follow-up based on disease progression. In our study, success and failure were considered to be assessed based on change in the target pressure.	day 1, week 1, months 1,3,6,9,12,18,24,30,36	No
Secondary	Number of anit-glaucoma medications		day 1, week 1, months 1,3,6,9,12,18,24,30,36	No
Secondary	Visual Acuity		day 1, week 1, months 1,3,6,9,12,18,24,30,36	No
Secondary	Mean deviation of visual field exam	Only visual field results where consecutive field tests did not show an improvement of 2 dB or more in the mean deviation (MD) over the baseline reading were included as we considered the phenomenon of learning effect in our analysis.	Months 6,12,18,24,30,36	No
Secondary	Surgical Success	Surgical failure was defined as persistent IOP of more than target pressure on maximally tolerated medications or IOP less than 6 mm Hg on two consecutive visits, phthisis bulbi, reduction of vision to no light perception, removal of the shunt implant, reoperation for glaucoma, or any devastating intraoperative and postoperative complications.	day 1, week 1, months 1,3,6,9,12,18,24,30,36	Yes

External Links

•   Primary Open Angle Glaucoma Preferred Practice Pattern