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Clinical Trials/NCT04151862
NCT04151862
Unknown
Not Applicable

Therapeutic Contact Lenses vs. Tight Bandage Patching and Pain Following Pterygium Excision: a Prospective Randomized Controlled Study

Soroka University Medical Center0 sites50 target enrollmentDecember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pterygium of Both Eyes
Sponsor
Soroka University Medical Center
Enrollment
50
Primary Endpoint
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.
Last Updated
6 years ago

Overview

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: 1. Demographic data such as: age, gender 2. Clinical data: best-corrected visual acuity (BCVA) full biomacroscopy examination, before surgery and at post-operative day (POD) 1 and 3 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.

Registry
clinicaltrials.gov
Start Date
December 1, 2019
End Date
June 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Erez Tsumi

Head of Ophthalmology Department

Soroka University Medical Center

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.

Outcomes

Primary Outcomes

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.

Time Frame: 1st Post Operative Day and 3rd Post Operative Day

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.

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