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Combined pars plana vitrectomy (PPV) and phacoemulsification (phaco) versus PPV and deferred phaco for phakic patients with full-thickness macular hole (FTMH) and no significant cataract at baseline: 1-year outcomes of a randomized trial combined PPV/phaco vs PPV/deferred phaco for MH

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Abstract

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.

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Disclaimer

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this manuscript.

Funding

The authors received financial support for the surgeries from FAEPA (Fundação de Apoio ao Ensino, Pesquisa e Assistência do HCFMRP-USP) and for the whole project from CNPq (Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), grant 305299/2018.

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Authors and Affiliations

  1. Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil

    Karlos Ítalo S. Viana, Camila T. Gordilho, Felipe P. P. Almeida, Marcelo M. Esperandio, David R. Lucena, Denny M. Garcia, André M. V. Messias & Rodrigo Jorge

  2. Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA

    Ingrid U. Scott

Authors
  1. Karlos Ítalo S. Viana
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  2. Camila T. Gordilho
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  3. Felipe P. P. Almeida
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  4. Marcelo M. Esperandio
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  9. Rodrigo Jorge
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Corresponding author

Correspondence to Rodrigo Jorge.

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The authors declare that they have no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the (Comitê de Ética em Pesquisa do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Viana, K.Í.S., Gordilho, C.T., Almeida, F.P.P. et al. Combined pars plana vitrectomy (PPV) and phacoemulsification (phaco) versus PPV and deferred phaco for phakic patients with full-thickness macular hole (FTMH) and no significant cataract at baseline: 1-year outcomes of a randomized trial combined PPV/phaco vs PPV/deferred phaco for MH. Graefes Arch Clin Exp Ophthalmol 259, 29–36 (2021). https://doi.org/10.1007/s00417-020-04731-7

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