Outcomes of Glaucoma Reoperations in the Primary Tube Versus Trabeculectomy Study

Sara J Coulon; Elizabeth A Vanner; Steven J Gedde; Primary Tube Versus Trabeculectomy Study Group

doi:10.1016/j.ogla.2023.02.003

Outcomes of Glaucoma Reoperations in the Primary Tube Versus Trabeculectomy Study

Ophthalmol Glaucoma. 2023 Jul-Aug;6(4):422-431. doi: 10.1016/j.ogla.2023.02.003. Epub 2023 Feb 22.

Authors

Sara J Coulon¹, Elizabeth A Vanner¹, Steven J Gedde²; Primary Tube Versus Trabeculectomy Study Group

Collaborators

Primary Tube Versus Trabeculectomy Study Group:
Steven J Gedde¹, Michael Banitt¹, Donald Budenz¹, Richard Lee¹, Paul Palmberg¹, Richard Parrish 2nd¹, Luis Vazquez¹, Sarah Wellik¹, Mark Werner¹, Jeffrey Zink³, Anup Khatana³, Davinder Grover⁴, Arvind Neelakantan⁴, Keith Barton⁵, Joseph Panarelli⁶, Paul Sidoti⁶, James Tsai⁶, Kateki Vinod⁶, Saurabh Goyal⁷, John Lind⁸, Steven Shields⁸, Kin Sheng Lim⁹, James Brandt¹⁰, Mark Sherwood¹¹, Mahmoud Khaimi¹², Prithvi Sankar¹³, Husam Ansari¹³, Eydie Miller-Ellis¹³, Robert Feldman¹⁴, Laura Baker¹⁴, Nicholas Bell¹⁴, Iqbal Ahmed¹⁵, Donna Williams¹⁵, Bruce Prum¹⁶, Pradeep Ramulu¹⁷, Henry Jampel¹⁷, William Feuer¹⁸, Luz Londono¹⁸, Joyce Schiffman¹⁸, Wei Shi¹⁸, Yolanda Silva¹⁸, Elizabeth Vanner¹⁸, Philip Chen¹⁹, Dale Heuer²⁰, Kuldev Singh²¹, Martha Wright²²

Affiliations

¹ Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
² Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: sgedde@med.miami.edu.
³ Cincinnati Eye Institute, Cincinnati, Ohio.
⁴ Glaucoma Associates of Texas, Dallas, Texas.
⁵ Moorfields Eye Hospital, London, United Kingdom.
⁶ New York Eye and Ear Infirmary, New York, New York.
⁷ Queen Mary's Hospital, Sidcup, United Kingdom.
⁸ St. Louis University, St. Louis, Missouri.
⁹ St. Thomas Hospital, London, United Kingdom.
¹⁰ University of California, Davis, Sacramento, California.
¹¹ University of Florida, Gainesville, Florida.
¹² University of Oklahoma, Oklahoma City, Oklahoma.
¹³ University of Pennsylvania, Philadelphia, Pennsylvania.
¹⁴ University of Texas Houston, Houston, Texas.
¹⁵ University of Toronto, Toronto, Canada.
¹⁶ University of Virginia, Charlottesville, Virginia.
¹⁷ Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland.
¹⁸ Statistical Coordinating Center, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, Florida.
¹⁹ University of Washington, Seattle, Washington.
²⁰ Medical College of Wisconsin, Milwaukee, Wisconsin.
²¹ Stanford University, Palo Alto, California.
²² University of Minnesota, Minneapolis, Minnesota.

PMID: 36828230
PMCID: PMC10440285 (available on 2024-07-01)
DOI: 10.1016/j.ogla.2023.02.003

Abstract

Purpose: To describe the incidence and outcomes of reoperations for glaucoma in the Primary Tube Versus Trabeculectomy (PTVT) Study.

Design: Cohort study of patients in a multicenter randomized clinical trial.

Participants: The PTVT Study enrolled 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery.

Methods: Randomization assigned 125 patients to placement of a tube shunt (350-mm² Baerveldt glaucoma implant) and 117 patients to trabeculectomy with mitomycin C (MMC, 0.4 mg/ml for 2 minutes). Data were analyzed from patients who underwent additional glaucoma surgery.

Main outcome measures: Outcome measures included intraocular pressure (IOP), use of glaucoma medications, visual acuity, surgical complications, and failure (IOP > 21 mmHg or reduced by <20%, IOP ≤ 5 mmHg, additional glaucoma surgery, or loss of light perception vision).

Results: Additional glaucoma surgery was performed in 21 patients in the tube group and 12 patients in the trabeculectomy group in the PTVT Study, and the 5-year cumulative reoperation rate for glaucoma was 18.0% in the tube group and 10.4% in the trabeculectomy group (P = 0.15). Follow-up (mean ± standard deviation [SD]) after additional glaucoma surgery was 35.1 ± 17.7 months in the tube group and 30.1 ± 17.6 months in the trabeculectomy group (P = 0.44). At 3 years after glaucoma reoperation, IOP (mean ± SD) was 15.5 ± 4.8 mmHg in the tube group and 16.6 ± 7.3 mmHg in the trabeculectomy group (P = 0.71). The number of glaucoma medications (mean ± SD) after 3 years of follow-up was 2.1 ± 1.7 in the tube group and 1.7 ± 1.0 in the trabeculectomy group (P = 0.58). The cumulative probability of failure at 3 years after a glaucoma reoperation was 37.8% in the tube group and 21.3% in the trabeculectomy group (P = 0.47).

Conclusion: No significant difference in the rate of reoperation for glaucoma was observed after tube shunt implantation and trabeculectomy with MMC in the PTVT Study. Similar surgical outcomes were observed after additional glaucoma surgery, irrespective of the initial procedure to which the patient was randomized.

Financial disclosure(s): Proprietary or commercial disclosure may be found after the references.

Keywords: Glaucoma surgery; Reoperation; Trabeculectomy; Tube shunt.

Publication types

Randomized Controlled Trial
Multicenter Study

MeSH terms

Cohort Studies
Glaucoma* / surgery
Humans
Mitomycin / pharmacology
Reoperation
Trabeculectomy* / methods
Treatment Outcome

Substances

Mitomycin

Grants and funding

P30 EY014801/EY/NEI NIH HHS/United States