title: Randomized comparison of postoperative use of hydrogel ocular bandage and collagen corneal shield for wound protection and patient tolerability after cataract surgery.
abstract: OBJECTIVE
  To compare the safety and efficacy of a hydrogel bandage and a collagen corneal shield in providing wound protection and relief of pain/discomfort in the acute period after uneventful unilateral clear corneal phacoemulsification cataract surgery with foldable intraocular lens (IOL) implantation.
  
  
  METHODS
  Seventeen investigational sites in the United States.
  
  
  METHODS
  Prospective randomized single-masked parallel study.
  
  
  METHODS
  The study comprised patients scheduled to have unilateral clear corneal cataract surgery with posterior chamber intraocular lens implantation. The patients were examined preoperatively and frequently for 30 days postoperatively. The design was a noninferiority study of the 2 primary endpoints, device performance and maximum reported postoperative pain.
  
  
  RESULTS
  The device performance success was 78.6% (228/290) for the hydrogel bandage and 26.5% (26/98) for the corneal shield (P<.0001 for noninferiority). Analyses indicated that the hydrogel bandage was superior to the corneal shield in device performance (P<.001; difference = 52.1%; 95% confidence interval, 41.6%-61.4%). The maximum postoperative pain/discomfort score of the hydrogel bandage (mean 1.3 ± 1.8 [SD]; scale 0 to 10) was noninferior to that of the corneal shield (1.1 ± 1.6) in the first 4 hours after surgery (P<.001). Adverse events in the cataract surgeries were reported in 22.2% (70/316) and 36.5% (38/104) of hydrogel bandage patients and corneal shield patients, respectively (P = .0045).
  
  
  CONCLUSIONS
  The hydrogel bandage was safe and effective for ocular surface protection and relief of pain/discomfort when applied topically to clear corneal incisions used in cataract or IOL implantation surgery.
  
  
  BACKGROUND
  No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.
authors.affiliation: Texan Eye, Austin, Texas, USA. steven@dellmd.com
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Dell
authors.forename: John A
authors.initials: JA
authors.lastname: Hovanesian
authors.forename: Michael B
authors.initials: MB
authors.lastname: Raizman
authors.forename: Alan S
authors.initials: AS
authors.lastname: Crandall
authors.forename: John
authors.initials: J
authors.lastname: Doane
authors.forename: Michael
authors.initials: M
authors.lastname: Snyder
authors.forename: Samuel
authors.initials: S
authors.lastname: Masket
authors.forename: Stephen
authors.initials: S
authors.lastname: Lane
authors.forename: Nicole
authors.initials: N
authors.lastname: Fram
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D047070:Bandages, Hydrocolloid; D003094:Collagen; D003315:Cornea / Q000601:surgery*; D005260:Female; D006801:Humans; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D010149:Postoperative Pain / Q000628:therapy; D017060:Patient Satisfaction; D018918:Phacoemulsification; D011182:Postoperative Care / Q000379:methods*; D011446:Prospective Studies; D016037:Single-Blind Method; D013530:Surgical Wound Infection / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003094:Collagen