Resumen de Anàlisi qualitativa i quantitativa de l'impacte de la cirurgia de cataracta a la superfície ocular
Purpose: To assess the effect of intracameral fixed combination of mydriatics and anaesthetic (ICMA) compared to standard mydriatic and anaesthetic eye drops on ocular surface.
Design: A phase IV, open-label, randomized clinical trial conducted in the Institute of Ocular Microsurgery (IMO, Barcelona,Spain).
Methods: 50 patients, aged 40 to 88 years, undergoing cataract surgery in both eyes were included in the study. ICMA was administered in one eye and the standard mydriatic/anaesthetic eye drops in the fellow eye. Before performing the cataract surgery in the first eye, subjects were randomized (1:1) to receive ICMA (with oxybuprocain chlorhydrate 0.4%+ tetracaine chlorhydrate 0.1%) or just eye drops (tropicamide 1%, phenylephrine 10% and oxybuprocain chlorhydrate 0.4% + tetracaine chlorhydrate 0.1%). Surgery of the fellow eye was performed within 7 days after the first surgery. All surgeries were performed by one single surgeon. Patients were evaluated before, immediately after, 1 day and 7 days after the surgery.
Results: Both groups presented similar preoperative data. The first postoperative day, the change from baseline in corneal and conjunctival surface staining was slightly less for ICMA, but not statistically significant. For the ICMA treated patients, corneal epithelial alterations were fewer the first postoperative day (p<0.005), conjunctival folliculo-papillary reaction was less frequent (p=0.015), ocular symptoms such as irritation/burning/stinging were less frequent and milder (p=0.018), length of procedure was shorter (p<0.001), and patient and investigator satisfaction were higher (p<0.05). Intraocular scattering and other postoperative changes generally favoured ICMA but were not statistically significant. Serious and related adverse events were not detected.
Conclusions: ICMA in routine cataract surgery reduced ocular surface damage by decreasing corneal epithelial and conjunctival toxicity with faster recovery of ocular surface integrity, compared to topical eye drops. ICMA shortened the procedure time, increased the intraoperative comfort, decreased the postoperative symptoms and improved patient and investigator satisfaction.
