PMID- 33196565
OWN - NLM
STAT- MEDLINE
DCOM- 20210728
LR  - 20230324
IS  - 1873-4502 (Electronic)
IS  - 0886-3350 (Linking)
VI  - 47
IP  - 5
DP  - 2021 May 1
TI  - 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.
PG  - 570-578
LID - 10.1097/j.jcrs.0000000000000491 [doi]
AB  - PURPOSE: To compare intracameral and topical mydriatics and anesthetics in 
      cataract surgery. SETTING: Institute of Ocular Microsurgery, Barcelona, Spain. 
      DESIGN: Phase IV, open-label, randomized, single-center study. METHODS: 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. 
      RESULTS: 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. CONCLUSIONS: 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.
CI  - Copyright (c) 2021 Published by Wolters Kluwer on behalf of ASCRS and ESCRS.
FAU - Souki, Spyridoula
AU  - Souki S
AD  - From the Institute of Ocular Microsurgery, Barcelona, Spain (Souki, Guell); CHU 
      Morvan, Brest, France (Cochener); Hopital Bicetre, Universite Paris Sud, Paris, 
      France (Labetoulle).
FAU - Cochener, Beatrice
AU  - Cochener B
FAU - Labetoulle, Marc
AU  - Labetoulle M
FAU - Guell, Jose Luis
AU  - Guell JL
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Cataract Refract Surg
JT  - Journal of cataract and refractive surgery
JID - 8604171
RN  - 0 (Anesthetics, Local)
RN  - 0 (Mydriatics)
RN  - 0 (Ophthalmic Solutions)
RN  - 98PI200987 (Lidocaine)
SB  - IM
MH  - Anesthetics, Local
MH  - *Cataract
MH  - Humans
MH  - Lidocaine
MH  - *Mydriatics
MH  - Ophthalmic Solutions
MH  - Prospective Studies
MH  - Spain
EDAT- 2020/11/17 06:00
MHDA- 2021/07/29 06:00
CRDT- 2020/11/16 14:48
PHST- 2020/08/17 00:00 [received]
PHST- 2020/10/10 00:00 [accepted]
PHST- 2020/11/17 06:00 [pubmed]
PHST- 2021/07/29 06:00 [medline]
PHST- 2020/11/16 14:48 [entrez]
AID - 02158034-202105000-00004 [pii]
AID - 10.1097/j.jcrs.0000000000000491 [doi]
PST - ppublish
SO  - J Cataract Refract Surg. 2021 May 1;47(5):570-578. doi: 
      10.1097/j.jcrs.0000000000000491.