Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01249235
First received: November 22, 2010
Last updated: November 24, 2010
Last verified: October 2010

November 22, 2010
November 24, 2010
October 2010
October 2010   (final data collection date for primary outcome measure)
Visual Analog Pain Score [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01249235 on ClinicalTrials.gov Archive Site
  • Sensitivity to light, tearing, foreign body sensation [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Postoperative Complications [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Difficulty removing the bandage lens, the bandage lens has fallen out, graft dislocation
  • Number of Tylenol #3 tablets required [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery
Prospective Randomized Controlled Trial Comparing Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery

The purpose of this study is to determine if patching the eye or a bandage contact lens along with Tylenol #3 is more effective for pain control following pterygium surgery.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pterygium
Procedure: Patch or bandage contact lens
Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.
  • Active Comparator: Patch
    The operative eye will be patched.
    Intervention: Procedure: Patch or bandage contact lens
  • Experimental: Bandage Contact Lens
    The operative eye will have a bandage contact lens
    Intervention: Procedure: Patch or bandage contact lens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
October 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision
  • Size of pterygium greater than 2.5 mm over the cornea (pterygia smaller than this do not result in much postoperative eye pain)
  • Ability to understand the nature of the procedure and to complete all measurement requirements
  • Adults (age greater than 18)

Exclusion Criteria:

  • Ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma)
  • Patients who have had previous ocular surface surgery
  • Contraindications to local anesthetics (such as known allergy)
  • Pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known)
  • Patients already on systemic analgesics for any other reason (such as rheumatoid arthritis)
  • Allergy to codeine (in order to standardize the systemic analgesic used so that we can compare the effect of bandage contact lens versus 24 hour patching)
Both
19 Years and older
No
Contact: Allan Slomovic, MD allan.slomovic@utoronto.ca
Canada
 
NCT01249235
REB-10-0538
Not Provided
Allan Slomovic, Toronto Western Hospital, University of Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Allan Slomovic, MD Toronto Western Hospital, University of Toronto
University Health Network, Toronto
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP