The ahmed versus baerveldt study

Three-year treatment outcomes

Panos G. Christakis, James C. Tsai, Jeffrey W. Kalenak, David Zurakowski, Louis Cantor, Jeffrey A. Kammer, Iqbal I K Ahmed

Research output: Contribution to journalArticle

102 Citations (Scopus)

Abstract

Objective: To compare 2 commonly used aqueous drainage devices for the treatment of refractory glaucoma. Design: International, multicenter, randomized trial. Participants: Patients aged 18 years or older with uncontrolled or high-risk glaucoma refractory to maximum medical therapy, many of whom had failed trabeculoplasty and trabeculectomy. Methods: Eligible patients were randomized to an Ahmed-FP7 valve implant (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA) using a standardized surgical technique. Main Outcome Measures: The primary outcome was failure, defined as intraocular pressure (IOP) outside of the target range (5-18 mmHg, with ≥20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, de novo glaucoma procedures, or loss of light perception. Secondary outcome measures include IOP, medication use, visual acuity, complications, and interventions. Results: A total of 238 patients were enrolled and randomized; 124 received the Ahmed implant and 114 received the Baerveldt implant. Baseline characteristics were similar in both groups. Half the study group had secondary glaucoma, and 37% had previously failed trabeculectomy. The mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. Median baseline Snellen visual acuity was 20/100. At 3 years, the cumulative probability of failure was 51% in the Ahmed group and 34% in the Baerveldt group (P = 0.03). Mean IOP was 15.7±4.8 mmHg in the Ahmed group (49% reduction) and 14.4±5.1 mmHg in the Baerveldt group (55% reduction; P = 0.09). Mean number of glaucoma medications was 1.8±1.4 in the Ahmed group (42% reduction) and 1.1±1.3 in the Baerveldt group (65% reduction; P = 0.002). There was a moderate but similar decrease in visual acuity in both groups (P < 0.001). The 2 groups had similar complication rates (52% Ahmed, 62% Baerveldt; P = 0.12); however, the Baerveldt group had a higher rate of hypotony-related vision-threatening complications (0% Ahmed, 6% Baerveldt; P = 0.005). More interventions were required in the Baerveldt group, although the difference did not reach statistical significance (38% Ahmed, 50% Baerveldt; P = 0.07). Most complications were transient, and most interventions were slit-lamp procedures. Conclusions: Both devices were effective in reducing IOP and glaucoma medications. The Baerveldt group had a lower failure rate and required fewer medications than the Ahmed group after 3 years, but it experienced more hypotony-related vision-threatening complications. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Original languageEnglish
Pages (from-to)2232-2240
Number of pages9
JournalOphthalmology
Volume120
Issue number11
DOIs
StatePublished - Nov 2013

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Glaucoma
Intraocular Pressure
Trabeculectomy
Glaucoma Drainage Implants
Visual Acuity
Outcome Assessment (Health Care)
Equipment and Supplies
Disclosure
Multicenter Studies
Drainage
Light
Therapeutics

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Christakis, P. G., Tsai, J. C., Kalenak, J. W., Zurakowski, D., Cantor, L., Kammer, J. A., & Ahmed, I. I. K. (2013). The ahmed versus baerveldt study: Three-year treatment outcomes. Ophthalmology, 120(11), 2232-2240. https://doi.org/10.1016/j.ophtha.2013.04.018

The ahmed versus baerveldt study : Three-year treatment outcomes. / Christakis, Panos G.; Tsai, James C.; Kalenak, Jeffrey W.; Zurakowski, David; Cantor, Louis; Kammer, Jeffrey A.; Ahmed, Iqbal I K.

In: Ophthalmology, Vol. 120, No. 11, 11.2013, p. 2232-2240.

Research output: Contribution to journalArticle

Christakis, PG, Tsai, JC, Kalenak, JW, Zurakowski, D, Cantor, L, Kammer, JA & Ahmed, IIK 2013, 'The ahmed versus baerveldt study: Three-year treatment outcomes', Ophthalmology, vol. 120, no. 11, pp. 2232-2240. https://doi.org/10.1016/j.ophtha.2013.04.018
Christakis PG, Tsai JC, Kalenak JW, Zurakowski D, Cantor L, Kammer JA et al. The ahmed versus baerveldt study: Three-year treatment outcomes. Ophthalmology. 2013 Nov;120(11):2232-2240. https://doi.org/10.1016/j.ophtha.2013.04.018
Christakis, Panos G. ; Tsai, James C. ; Kalenak, Jeffrey W. ; Zurakowski, David ; Cantor, Louis ; Kammer, Jeffrey A. ; Ahmed, Iqbal I K. / The ahmed versus baerveldt study : Three-year treatment outcomes. In: Ophthalmology. 2013 ; Vol. 120, No. 11. pp. 2232-2240.
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abstract = "Objective: To compare 2 commonly used aqueous drainage devices for the treatment of refractory glaucoma. Design: International, multicenter, randomized trial. Participants: Patients aged 18 years or older with uncontrolled or high-risk glaucoma refractory to maximum medical therapy, many of whom had failed trabeculoplasty and trabeculectomy. Methods: Eligible patients were randomized to an Ahmed-FP7 valve implant (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA) using a standardized surgical technique. Main Outcome Measures: The primary outcome was failure, defined as intraocular pressure (IOP) outside of the target range (5-18 mmHg, with ≥20{\%} reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, de novo glaucoma procedures, or loss of light perception. Secondary outcome measures include IOP, medication use, visual acuity, complications, and interventions. Results: A total of 238 patients were enrolled and randomized; 124 received the Ahmed implant and 114 received the Baerveldt implant. Baseline characteristics were similar in both groups. Half the study group had secondary glaucoma, and 37{\%} had previously failed trabeculectomy. The mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. Median baseline Snellen visual acuity was 20/100. At 3 years, the cumulative probability of failure was 51{\%} in the Ahmed group and 34{\%} in the Baerveldt group (P = 0.03). Mean IOP was 15.7±4.8 mmHg in the Ahmed group (49{\%} reduction) and 14.4±5.1 mmHg in the Baerveldt group (55{\%} reduction; P = 0.09). Mean number of glaucoma medications was 1.8±1.4 in the Ahmed group (42{\%} reduction) and 1.1±1.3 in the Baerveldt group (65{\%} reduction; P = 0.002). There was a moderate but similar decrease in visual acuity in both groups (P < 0.001). The 2 groups had similar complication rates (52{\%} Ahmed, 62{\%} Baerveldt; P = 0.12); however, the Baerveldt group had a higher rate of hypotony-related vision-threatening complications (0{\%} Ahmed, 6{\%} Baerveldt; P = 0.005). More interventions were required in the Baerveldt group, although the difference did not reach statistical significance (38{\%} Ahmed, 50{\%} Baerveldt; P = 0.07). Most complications were transient, and most interventions were slit-lamp procedures. Conclusions: Both devices were effective in reducing IOP and glaucoma medications. The Baerveldt group had a lower failure rate and required fewer medications than the Ahmed group after 3 years, but it experienced more hypotony-related vision-threatening complications. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.",
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T2 - Three-year treatment outcomes

AU - Christakis, Panos G.

AU - Tsai, James C.

AU - Kalenak, Jeffrey W.

AU - Zurakowski, David

AU - Cantor, Louis

AU - Kammer, Jeffrey A.

AU - Ahmed, Iqbal I K

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N2 - Objective: To compare 2 commonly used aqueous drainage devices for the treatment of refractory glaucoma. Design: International, multicenter, randomized trial. Participants: Patients aged 18 years or older with uncontrolled or high-risk glaucoma refractory to maximum medical therapy, many of whom had failed trabeculoplasty and trabeculectomy. Methods: Eligible patients were randomized to an Ahmed-FP7 valve implant (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA) using a standardized surgical technique. Main Outcome Measures: The primary outcome was failure, defined as intraocular pressure (IOP) outside of the target range (5-18 mmHg, with ≥20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, de novo glaucoma procedures, or loss of light perception. Secondary outcome measures include IOP, medication use, visual acuity, complications, and interventions. Results: A total of 238 patients were enrolled and randomized; 124 received the Ahmed implant and 114 received the Baerveldt implant. Baseline characteristics were similar in both groups. Half the study group had secondary glaucoma, and 37% had previously failed trabeculectomy. The mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. Median baseline Snellen visual acuity was 20/100. At 3 years, the cumulative probability of failure was 51% in the Ahmed group and 34% in the Baerveldt group (P = 0.03). Mean IOP was 15.7±4.8 mmHg in the Ahmed group (49% reduction) and 14.4±5.1 mmHg in the Baerveldt group (55% reduction; P = 0.09). Mean number of glaucoma medications was 1.8±1.4 in the Ahmed group (42% reduction) and 1.1±1.3 in the Baerveldt group (65% reduction; P = 0.002). There was a moderate but similar decrease in visual acuity in both groups (P < 0.001). The 2 groups had similar complication rates (52% Ahmed, 62% Baerveldt; P = 0.12); however, the Baerveldt group had a higher rate of hypotony-related vision-threatening complications (0% Ahmed, 6% Baerveldt; P = 0.005). More interventions were required in the Baerveldt group, although the difference did not reach statistical significance (38% Ahmed, 50% Baerveldt; P = 0.07). Most complications were transient, and most interventions were slit-lamp procedures. Conclusions: Both devices were effective in reducing IOP and glaucoma medications. The Baerveldt group had a lower failure rate and required fewer medications than the Ahmed group after 3 years, but it experienced more hypotony-related vision-threatening complications. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

AB - Objective: To compare 2 commonly used aqueous drainage devices for the treatment of refractory glaucoma. Design: International, multicenter, randomized trial. Participants: Patients aged 18 years or older with uncontrolled or high-risk glaucoma refractory to maximum medical therapy, many of whom had failed trabeculoplasty and trabeculectomy. Methods: Eligible patients were randomized to an Ahmed-FP7 valve implant (New World Medical, Inc., Rancho Cucamonga, CA) or a Baerveldt-350 implant (Abbott Medical Optics, Inc., Santa Ana, CA) using a standardized surgical technique. Main Outcome Measures: The primary outcome was failure, defined as intraocular pressure (IOP) outside of the target range (5-18 mmHg, with ≥20% reduction from baseline) for 2 consecutive visits after 3 months, vision-threatening complications, de novo glaucoma procedures, or loss of light perception. Secondary outcome measures include IOP, medication use, visual acuity, complications, and interventions. Results: A total of 238 patients were enrolled and randomized; 124 received the Ahmed implant and 114 received the Baerveldt implant. Baseline characteristics were similar in both groups. Half the study group had secondary glaucoma, and 37% had previously failed trabeculectomy. The mean preoperative IOP was 31.4±10.8 mmHg on 3.1±1.0 glaucoma medications. Median baseline Snellen visual acuity was 20/100. At 3 years, the cumulative probability of failure was 51% in the Ahmed group and 34% in the Baerveldt group (P = 0.03). Mean IOP was 15.7±4.8 mmHg in the Ahmed group (49% reduction) and 14.4±5.1 mmHg in the Baerveldt group (55% reduction; P = 0.09). Mean number of glaucoma medications was 1.8±1.4 in the Ahmed group (42% reduction) and 1.1±1.3 in the Baerveldt group (65% reduction; P = 0.002). There was a moderate but similar decrease in visual acuity in both groups (P < 0.001). The 2 groups had similar complication rates (52% Ahmed, 62% Baerveldt; P = 0.12); however, the Baerveldt group had a higher rate of hypotony-related vision-threatening complications (0% Ahmed, 6% Baerveldt; P = 0.005). More interventions were required in the Baerveldt group, although the difference did not reach statistical significance (38% Ahmed, 50% Baerveldt; P = 0.07). Most complications were transient, and most interventions were slit-lamp procedures. Conclusions: Both devices were effective in reducing IOP and glaucoma medications. The Baerveldt group had a lower failure rate and required fewer medications than the Ahmed group after 3 years, but it experienced more hypotony-related vision-threatening complications. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

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