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PLoS One. 2018 Jul 11;13(7):e0200365. doi: 10.1371/journal.pone.0200365. eCollection 2018.

Biomarkers and predictors for functional and anatomic outcomes for small gauge pars plana vitrectomy and peeling of the internal limiting membrane in naïve diabetic macular edema: The VITAL Study.

Author information

1
Private Retina Service, University of Buenos Aires, Buenos Aires, Argentina.
2
NITIDO: Nuevo Instituto Tucumano de Investigación y Desarrollo en Oftalmología, Tucuman, Argentina.
3
Department of General Ophthalmology and Pediatric Ophthalmology Service, Medical University in Lublin, Lublin, Poland.
4
Eye Surgery Center Professor Zagorski, Lublin, Poland.
5
Diagnostic Ophthalmological Center, Buenos Aires, Argentina.
6
Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.
7
Smt.Kanuri Santhamma Retina Vitreous Centre, L.V.Prasad Eye Institute Kallam Anji Reddy Campus, Hyderabad, India.
8
Department of Ophthalmology, University of Leipzig, Leipzig, Germany.
9
Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
10
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
11
Incumbent, Sydney A. Fox chair in Ophthalmology, Tel Aviv University, Tel Aviv, Israel.

Abstract

PURPOSE:

We aimed to investigate biomarkers and predictive factors for visual and anatomical outcome in patients with naïve diabetic macular edema (DME) who underwent small gauge pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling as a first line treatment.

DESIGN:

Multicenter, retrospective, interventional study.

PARTICIPANTS:

120 eyes from 120 patients with naïve DME treated with PPV and ILM peeling with a follow up of 24 months.

METHODS:

Change in baseline best corrected visual acuity (BCVA) and central subfoveal thickness (CST) 1, 6, 12 and 24 months after surgery. Predictive value of baseline BCVA, CST, optical coherence tomography (OCT) features (presence of subretinal fluid (SRF) and photoreceptor damage), and time between DME diagnosis and surgery. Additional treatment for DME needed. Intra- and post-operative complications (cataract rate formation, increased intraocular pressure).

MAIN OUTCOME MEASURES:

The correlation between baseline characteristics and BCVA response (mean change from baseline; categorized improvement ≥5 or ≥10; Early Treatment Diabetic Retinopathy Study (ETDRS) letters) 12 and 24 months after surgery.

RESULTS:

Mean BCVA was 0.66 ± 0.14 logMAR, 0.52 ± 0.21 logMAR, and 0.53 ± 0.21 logMAR (p<0.001) at baseline, 12 and 24 months, respectively. Shorter time from DME diagnosis until PPV (OR: 0.98, 95% CI: 0.97-0.99, p<0.001) was a predictor for good functional treatment response (area under the curve 0.828). For every day PPV is postponed, the patient's chances to gain ≥5 letters at 24 months decrease by 1.8%. Presence of SRF was identified as an anatomical predictor of a better visual outcome, (OR: 6.29, 95% CI: 1.16-34.08, p = 0.033). Safety profile was acceptable.

CONCLUSIONS:

Our results reveal a significant functional and anatomical improvement of DME 24 months after primary PPV, without the need for additional treatment. Early surgical intervention and presence of SRF predict good visual outcome. These biomarkers should be considered when treatment is chosen.

PMID:
29995929
PMCID:
PMC6040739
DOI:
10.1371/journal.pone.0200365
[Indexed for MEDLINE]
Free PMC Article

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