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
  Purpose

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.


Condition Intervention
Pterygium
Procedure: Patch or bandage contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial Comparing Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Visual Analog Pain Score [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Patch
The operative eye will be patched.
Procedure: Patch or bandage contact lens
Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.
Experimental: Bandage Contact Lens
The operative eye will have a bandage contact lens
Procedure: Patch or bandage contact lens
Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249235

Contacts
Contact: Allan Slomovic, MD allan.slomovic@utoronto.ca

Locations
Canada, Ontario
Toronto Western Hospital, University of Toronto Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Sonia Yeung, MD       sonia.yeung@utoronto.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Allan Slomovic, MD Toronto Western Hospital, University of Toronto
  More Information

No publications provided

Responsible Party: Allan Slomovic, Toronto Western Hospital, University of Toronto
ClinicalTrials.gov Identifier: NCT01249235     History of Changes
Other Study ID Numbers: REB-10-0538
Study First Received: November 22, 2010
Last Updated: November 24, 2010
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014