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Table 1 Summary of results of previous clinical trials using 5-FU combined with LMWH during pars plana vitrectomy

From: Prophylactic intravitreal 5-fluorouracil and heparin to prevent proliferative vitreoretinopathy in high-risk patients with retinal detachment: study protocol for a randomized controlled trial

Reference

Intervention

(Dose and duration of trial drug)

Number of treated eyes (n)

(treatment arm)

and follow-up period

Main inclusion criterion

(PVR grade)

Endpoint

Results

Asaria et al. [7]

200 μg/mL 5-FU and 5 IU/mL LMWH (in 500 mL intraocular BSS)

n = 174 (87)

Follow-up: 6 months

High-risk eyes for PVR

Incidence of PVR,

re-detachment rate after 6 months, rate of re-operations to achieve stable re-attachment, visual acuity.

Statistically significant reduction in incidence of PVR (12.6% versus 26.4%; P = 0.02).

Charteris et al. [11]

200 μg/mL 5-FU and 5 IU/mL LMWH (in 500 mL intraocular BSS - duration 1 h during pars plana vitrectomy with silicone oil tamponade)

n = 157 (78)

Follow-up: 6 months

PVR grade C

Primary: re-attachment rate following silicone oil removal without necessity of additional surgical interventions.

Secondary: visual acuity,

formation of epiretinal membranes,

glaucoma,

cataract,

localized retinal detachments.

No statistically significant difference between both groups regarding primary or secondary endpoints.

Wickham et al. [9]

200 μg/mL 5-FU and 5 IU/mL LMWH (in 500 mL intraocular BSS - duration 1 h)

n = 641 (342)

Follow-up: 6 months

No pre-existing PVR

Primary: re-attachment rate without secondary intervention after 6 months.

Secondary: incidence of PVR,

visual acuity, postoperative complication rate.

No statistically significant difference between both groups regarding primary endpoint (82.3% versus 86.8%);

No statistically significant difference regarding visual acuity overall (P = 0.072) but worse outcome in eyes with primarily attached macula (P = 0.0091).

  1. Abbreviations: 5-FU 5-fluorouracil, BSS balanced salt solution, LMWH low-molecular-weight heparin, PVR proliferative vitreoretinopathy