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Visual Field Outcomes in the Primary Tube Versus Trabeculectomy Study.

Ophthalmology 2024 April 5
PURPOSE: To describe visual field outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study.

DESIGN: Cohort analysis of a prospective multicenter randomized clinical trial.

SUBJECTS: A total of 155 eyes from 155 subjects randomly assigned to treatment with tube shunt surgery (n=84) or trabeculectomy with mitomycin C (n=71).

METHODS: The PTVT Study was a multicenter randomized clinical trial comparing the safety and efficacy of trabeculectomy and tube shunt surgery in eyes without prior intraocular surgery. Subjects underwent standard automated perimetry (SAP) at baseline and annually for five years. SAP tests were deemed reliable if the false positive rate was ≤15%. Tests were excluded if visual acuity was ≤20/400 or loss of ≥2 Snellen lines from baseline were attributed to a non-glaucomatous etiology. Linear mixed-effects models were used to compare rates of change in SAP mean deviation (MD) between the two treatment groups. Intraocular pressure (IOP) control was assessed by percentage of visits with IOP <18 mmHg and mean IOP.

OUTCOME MEASURES: Rate of change in SAP MD during follow-up.

RESULTS: A total of 730 SAP tests were evaluated, with an average of 4.7 tests per eye. The average SAP MD at baseline was -12.8±8.3 dB in the tube group and -12.0±8.4 dB in the trabeculectomy group (p=0.57). The mean rate of change in SAP MD was -0.32±0.39 dB/year in the trabeculectomy group and -0.47±0.43 dB/year in the tube group (p=0.23). Eyes with mean IOP 14-17.5 mmHg had significantly faster rates of SAP MD loss compared to eyes with mean IOP <14 mmHg (-0.59±0.13 vs. -0.27±0.08 dB/year, p=0.012) and eyes with only 50-75% of visits with IOP <18 mmHg had faster rates than those with 100% of visits with IOP <18 mmHg (-0.90±0.16 vs. -0.29±0.08 dB/year, p<0.001). Multivariable analysis identified older age and worse IOP control as risk factors for faster progression in both treatment groups.

CONCLUSIONS: No statistically significant difference in mean rates of visual field change was observed between trabeculectomy and tube shunt surgery in the PTVT Study. Worse IOP control was significantly associated with faster rates of SAP MD loss during follow-up. Older patients were also at risk for faster progression.

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