Phase IV clinical study to evaluate the effects of an intracameral combined mydriatic and anesthetic agent and standard topical mydriatics and anesthetics on the ocular surface after cataract surgery.
Journal
Journal of cataract and refractive surgery
ISSN: 1873-4502
Titre abrégé: J Cataract Refract Surg
Pays: United States
ID NLM: 8604171
Informations de publication
Date de publication:
01 May 2021
01 May 2021
Historique:
received:
17
08
2020
accepted:
10
10
2020
pubmed:
17
11
2020
medline:
29
7
2021
entrez:
16
11
2020
Statut:
ppublish
Résumé
To compare intracameral and topical mydriatics and anesthetics in cataract surgery. Institute of Ocular Microsurgery, Barcelona, Spain. Phase IV, open-label, randomized, single-center study. Patients were randomized in a 1:1 ratio to receive intracameral mydriatic-anesthetic (Mydrane/Fydrane) and anesthetic eyedrops or control (topical eyedrops only). The other treatment was administered for the second cataract surgery. Assessments were performed at presurgery and immediately postsurgery, at 12 to 36 hours postsurgery (day 1), and 7 days postsurgery. The primary endpoint was the change from baseline in corneal/conjunctival surface staining. The secondary endpoints included assessments of epithelial alterations, point-spread function, ocular surface disease index, conjunctival hyperemia, vision breakup time, ocular symptoms/signs, adverse events (AEs), corrected distance visual acuity, intraocular pressure, patient/investigator satisfaction, and procedure time. A total of 50 patients undergoing sequential cataract surgery in both eyes were included. Baseline assessments were similar in each group. The difference between Fydrane and control groups for the change from baseline at day 1 in corneal and conjunctival surface staining was not statistically significant. For Fydrane, postoperative epithelial alterations were fewer at day 1 (P < .005), folliculopapillary reaction was less frequent (P < .05), some ocular symptoms were less frequent and milder (P < .05), length of procedure was shorter (P < .001), and patient and investigator satisfaction were better (P < .05). There were few AEs in both groups. Fydrane reduced ocular surface damage by decreasing corneal epithelial and conjunctival toxicity with faster recovery of surface integrity compared with topical eyedrops, improved patient and investigator satisfaction, and reduced procedure time.
Identifiants
pubmed: 33196565
pii: 02158034-202105000-00004
doi: 10.1097/j.jcrs.0000000000000491
doi:
Substances chimiques
Anesthetics, Local
0
Mydriatics
0
Ophthalmic Solutions
0
Lidocaine
98PI200987
Types de publication
Clinical Trial, Phase IV
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
570-578Informations de copyright
Copyright © 2021 Published by Wolters Kluwer on behalf of ASCRS and ESCRS.
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