PURPOSE: To compare functional and anatomic outcomes of combined pars plana vitrectomy (PPV) and phacoemulsification (phaco) versus PPV and deferred phaco in patients with full-thickness macular hole (FTMH) and no significant cataract. METHODS: Thirty-four patients were randomized to group 1 (combined PPV/phaco) and 34 to group 2 (PPV/deferred phaco). Group 2 patients could undergo phaco any time after FTMH surgery if significant cataract developed. RESULTS: Sixty-five patients (33 group 1 and 32 group 2) completed the 12-month visit. Mean ±SEM logMAR best-corrected visual acuity (BCVA) was 0.92 ± 0.04 and 0.90 ± 0.04 at baseline and improved significantly to 0.60 ± 0.05 and 0.58 ± 0.05 at month 12 (p < 0.0001) in groups 1 and 2, respectively. There was no significant difference between the groups in mean BCVA at baseline or at month 12. Mean macular sensitivity (dB) was 18.22 ± 0.93 and 16.72 ± 0.93 at baseline and increased to 21.13 ± 0.86 and 21.07 ± 0.85 in groups 1 and 2, respectively (p < 0.05) with no significant difference between the groups (p = 0.449) at month 12. FTMH closure rate was 73% and 75% in groups 1 and 2, respectively (p = 0.834). CONCLUSION: Among patients with FTMH and no significant cataract at baseline, combined PPV/phaco was associated with similar BCVA, microperimetry, and FTMH closure outcomes at 1-year compared with PPV/deferred phaco. TRIAL REGISTRATION: ( clinicaltrials.gov.br ): Ensaios clínicos brasileiros: RBR-3wmd9s; UTN number: U1111-1190-5013; Plataforma Brasil CAAE number: 50455415.3.0000.5440; IRB number: 1.433.000.
RCT Entities:
PURPOSE: To compare functional and anatomic outcomes of combined pars plana vitrectomy (PPV) and phacoemulsification (phaco) versus PPV and deferred phaco in patients with full-thickness macular hole (FTMH) and no significant cataract. METHODS: Thirty-four patients were randomized to group 1 (combined PPV/phaco) and 34 to group 2 (PPV/deferred phaco). Group 2 patients could undergo phaco any time after FTMH surgery if significant cataract developed. RESULTS: Sixty-five patients (33 group 1 and 32 group 2) completed the 12-month visit. Mean ± SEM logMAR best-corrected visual acuity (BCVA) was 0.92 ± 0.04 and 0.90 ± 0.04 at baseline and improved significantly to 0.60 ± 0.05 and 0.58 ± 0.05 at month 12 (p < 0.0001) in groups 1 and 2, respectively. There was no significant difference between the groups in mean BCVA at baseline or at month 12. Mean macular sensitivity (dB) was 18.22 ± 0.93 and 16.72 ± 0.93 at baseline and increased to 21.13 ± 0.86 and 21.07 ± 0.85 in groups 1 and 2, respectively (p < 0.05) with no significant difference between the groups (p = 0.449) at month 12. FTMH closure rate was 73% and 75% in groups 1 and 2, respectively (p = 0.834). CONCLUSION: Among patients with FTMH and no significant cataract at baseline, combined PPV/phaco was associated with similar BCVA, microperimetry, and FTMH closure outcomes at 1-year compared with PPV/deferred phaco. TRIAL REGISTRATION: ( clinicaltrials.gov.br ): Ensaios clínicos brasileiros: RBR-3wmd9s; UTN number: U1111-1190-5013; Plataforma Brasil CAAE number: 50455415.3.0000.5440; IRB number: 1.433.000.