Bandage Contact Lenses Versus Eye Patching of Müller's Muscle-conjunctival Resection
Primary Purpose
Eyelid Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
bandage contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Eyelid Diseases focused on measuring patient comfort
Eligibility Criteria
Inclusion Criteria:
- Patients who had unilateral ptosis and underwent unilateral MMCR
Exclusion Criteria:
- Patients were excluded if they had previous eyelid surgery or had another known eye disease, such as ocular surface disorders, dry eye syndrome.
Sites / Locations
- Haydarpasa Numune Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
bandage contact lens
eye patching
Arm Description
A bandage contact lens was applied on the eye at the end of the surgery, and the eye was not covered with a patch.
Antibiotic eye ointment was applied on the eye, and the eye was covered with a patch at the end of the surgery.
Outcomes
Primary Outcome Measures
patient comfort
VAS scores, (0: lowest; 10: highest)
patient comfort
TBUT score, (the minimum score was 0, and the maximum score was 15)
Secondary Outcome Measures
Full Information
NCT ID
NCT04554329
First Posted
August 7, 2020
Last Updated
September 13, 2020
Sponsor
Haydarpasa Numune Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04554329
Brief Title
Bandage Contact Lenses Versus Eye Patching of Müller's Muscle-conjunctival Resection
Official Title
Efficacy of Bandage Contact Lenses Versus Eye Patching in Early Postoperative Period of Müller's Muscle-conjunctival Resection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haydarpasa Numune Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Patients with blepharoptosis who are treated with Müller's muscle-conjunctival resection (MMCR) may experience postoperative pain and discomfort related to the suture material on the palpebral conjunctiva. This study aims to compare the postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the cornea with a tear break-up time (TBUT) test and fluorescein staining following MMCR that was managed by either a bandage contact lens (BCL) or eye patching.
Detailed Description
Patients with blepharoptosis who are treated with Müller's muscle-conjunctival resection (MMCR) may experience postoperative pain and discomfort related to the suture material on the palpebral conjunctiva. This study aims to compare the postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the cornea with a tear break-up time (TBUT) test and fluorescein staining following MMCR that was managed by either a bandage contact lens (BCL) or eye patching.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Diseases
Keywords
patient comfort
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bandage contact lens
Arm Type
Active Comparator
Arm Description
A bandage contact lens was applied on the eye at the end of the surgery, and the eye was not covered with a patch.
Arm Title
eye patching
Arm Type
Active Comparator
Arm Description
Antibiotic eye ointment was applied on the eye, and the eye was covered with a patch at the end of the surgery.
Intervention Type
Procedure
Intervention Name(s)
bandage contact lens
Intervention Description
bandage contact lens
Primary Outcome Measure Information:
Title
patient comfort
Description
VAS scores, (0: lowest; 10: highest)
Time Frame
1 week
Title
patient comfort
Description
TBUT score, (the minimum score was 0, and the maximum score was 15)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who had unilateral ptosis and underwent unilateral MMCR
Exclusion Criteria:
Patients were excluded if they had previous eyelid surgery or had another known eye disease, such as ocular surface disorders, dry eye syndrome.
Facility Information:
Facility Name
Haydarpasa Numune Education and Research Hospital
City
Istanbul
State/Province
Marmara
ZIP/Postal Code
34668
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bandage Contact Lenses Versus Eye Patching of Müller's Muscle-conjunctival Resection
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