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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
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium of Both Eyes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 27, 2019
    Last Updated
    November 6, 2019
    Sponsor
    Soroka University Medical Center
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    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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