The Two Most Common Ways Post-operative Eye Patch Are Therapeutic Contact Lenses (TCL) and Overnight Bandaging With Tight Bandage Patch: This Study is Designed to Determine the Most Effective Post-operative Care to Relief the Patient's Discomfort After Pterygium Excision Surgery
Primary Purpose
Pterygium of Both Eyes, Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tight eye bandage
Soflex Soft Contact Lens
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium of Both Eyes
Eligibility Criteria
Inclusion Criteria:
- healthy patients with no significant ocular diseases, older than 18 year old with both eyes pterygia, referred for surgery and which are interested of their own will for pterygium excision surgery.
Exclusion Criteria:
- patients younger than 18 years old
- patients with chronic diseases of the immune system
- chronic diseases of eyelid or ocular surface, history of previous ocular surgery or trauma
- collagen vascular disease or diabetes mellitus chronic
- ingestion of pain killers.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tight eye bandage
therapeutic contact lenses (TCL)
Arm Description
Both eyes will be operated at two separate sessions. In the first session the first 25 patients will be bandaged postoperatively with tight eye bandage patching.
Both eyes will be operated at two separate sessions. In the second session the 25 patients will be bandaged postoperatively with therapeutic contact lenses (TCL).
Outcomes
Primary Outcome Measures
Measurment of pain and discomfort for patients post pterygium excision: Visual Analog Scale by questionnaire on marking straight horizontal line of fixed length from 0-100 mm where 0 mm is no pain and 100 mm is maximal pain.
Assessing pain and discomfort comparing the two groups ( one with tight bandage and the other with contact lens).post pterygium excision by the change in pain scores on Visual Analog Scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT04151862
First Posted
October 27, 2019
Last Updated
November 6, 2019
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04151862
Brief Title
The Two Most Common Ways Post-operative Eye Patch Are Therapeutic Contact Lenses (TCL) and Overnight Bandaging With Tight Bandage Patch: This Study is Designed to Determine the Most Effective Post-operative Care to Relief the Patient's Discomfort After Pterygium Excision Surgery
Official Title
Therapeutic Contact Lenses vs. Tight Bandage Patching and Pain Following Pterygium Excision: a Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to determine the most effective post-operative care to relief the patient's discomfort after pterygium excision surgery.
Detailed Description
This is a prospective, randomized controlled trial. 50 patients with primary pterygium in both eyes for whom surgery was advised, will be recruited to the study. Criteria for pterygium excision surgery is mostly cosmetic, local eye symptoms, or visual impairment.
The following data will be collected and analyzed:
Demographic data such as: age, gender
Clinical data: best-corrected visual acuity (BCVA) full biomacroscopy examination, before surgery and at post-operative day (POD) 1 and 3
Symptoms and discomfort: Visual Analogue Scale (VAS) score and pain killer use. The differences in these variables values preoperatively and on the first and 3rd postoperative day will compared between the two treated eyes.
Surgical technique and postoperative care
All patients will be operated for the same pterygium excision under local anesthesia in the formal accepted surgical method. All patients will be treated with ofloxacin drops + dexamethasone drops four times daily during the first postoperative week. The only difference is that one group will be bandaged with tight bandage patching and the other with therapeutic contact lenses (TCL) only for the first 24 hours.
Patient-centered outcome
Discomfort and pain will be evaluated on the follow-up meeting on the first and 3rd postoperative day. The patient will be asked to rate pain and discomfort for each operated eye on pain scale of VAS ranking the pain on a line from No pain at 0 cm to worst possible pain at 10 cm and the estimated pain given by the patient's translation of pain into spot on a line.
Patients will also be queried about the number of hours during which they feel pain, and the number of pain killers used ( every patient will be given prescription for 3 tabs of Paracetamol 500 mg (giving no drugs sensitivity for paracetamol) on POD 1 & 3).
Their sleep quality will rated according to whether they reported having a full night's sleep and the number of times they were awoken due to pain/discomfort.
Statistical analysis
The t test was used to calculate differences in numerical variables (VA, hours of pain, number of pain killers, etc.). Non-parametric Wilcoxon Mann-Whitney was used to calculate differences in non-numerical variables such as pain level (VAS scale). Chi-square analyses were used to calculate proportional group differences (e.g., use of pain killers and sleep pattern). The overall significance level was set to a value of 0.05. The statistical analysis was carried out using Microsoft Excel 2013.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium of Both Eyes, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tight eye bandage
Arm Type
Active Comparator
Arm Description
Both eyes will be operated at two separate sessions. In the first session the first 25 patients will be bandaged postoperatively with tight eye bandage patching.
Arm Title
therapeutic contact lenses (TCL)
Arm Type
Active Comparator
Arm Description
Both eyes will be operated at two separate sessions. In the second session the 25 patients will be bandaged postoperatively with therapeutic contact lenses (TCL).
Intervention Type
Device
Intervention Name(s)
tight eye bandage
Other Intervention Name(s)
Nissan LTD
Intervention Description
sterile eye pad made of 100% cotton
Intervention Type
Device
Intervention Name(s)
Soflex Soft Contact Lens
Other Intervention Name(s)
SOFLEX LTD (TH78)
Intervention Description
Therapeutic contact lenses (TCL)
Primary Outcome Measure Information:
Title
Measurment of pain and discomfort for patients post pterygium excision: Visual Analog Scale by questionnaire on marking straight horizontal line of fixed length from 0-100 mm where 0 mm is no pain and 100 mm is maximal pain.
Description
Assessing pain and discomfort comparing the two groups ( one with tight bandage and the other with contact lens).post pterygium excision by the change in pain scores on Visual Analog Scale.
Time Frame
1st Post Operative Day and 3rd Post Operative Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
healthy patients with no significant ocular diseases, older than 18 year old with both eyes pterygia, referred for surgery and which are interested of their own will for pterygium excision surgery.
Exclusion Criteria:
patients younger than 18 years old
patients with chronic diseases of the immune system
chronic diseases of eyelid or ocular surface, history of previous ocular surgery or trauma
collagen vascular disease or diabetes mellitus chronic
ingestion of pain killers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tal Koren, MD
Phone
+972523606310
Email
tuli_pi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erez Tzumi, MD
Organizational Affiliation
Head of ophthalmology department
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Two Most Common Ways Post-operative Eye Patch Are Therapeutic Contact Lenses (TCL) and Overnight Bandaging With Tight Bandage Patch: This Study is Designed to Determine the Most Effective Post-operative Care to Relief the Patient's Discomfort After Pterygium Excision Surgery
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