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
Recruitment status was Recruiting
Sponsor:
University Health Network, Toronto
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
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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
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 May 23, 2013