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

NCT04151862 | Unknown DMC

• 1 other identifier: 0145-19 SOR
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to determine the most effective post-operative care to relief the patient's discomfort after pterygium excision surgery.

Conditions

Pterygium of Both Eyes; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  1st Post Operative Day and 3rd Post Operative Day

Study Arms (2)

tight eye bandage

ACTIVE COMPARATOR

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.

Device: tight eye bandage

therapeutic contact lenses (TCL)

ACTIVE COMPARATOR

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).

Device: Soflex Soft Contact Lens

Interventions

tight eye bandage DEVICE

sterile eye pad made of 100% cotton

Also known as: Nissan LTD

tight eye bandage

Soflex Soft Contact Lens DEVICE

Therapeutic contact lenses (TCL)

Also known as: SOFLEX LTD (TH78)

therapeutic contact lenses (TCL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soroka University Medical Center: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Erez Tzumi, MD

  Head of ophthalmology department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tal Koren, MD

CONTACT

+972523606310; tuli_pi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmology Department

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: November 5, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share