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Bandage Contact Lenses Versus Eye Patching of Müller's Muscle-conjunctival Resection

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ClinicalTrials.gov Identifier: NCT04554329
Recruitment Status : Completed
First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mehmet Serhat Mangan, Haydarpasa Numune Training and Research Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eyelid Diseases Procedure: bandage contact lens Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Bandage Contact Lenses Versus Eye Patching in Early Postoperative Period of Müller's Muscle-conjunctival Resection
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : August 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: bandage contact lens
A bandage contact lens was applied on the eye at the end of the surgery, and the eye was not covered with a patch.
 Procedure: bandage contact lens
bandage contact lens
Active Comparator: eye patching
Antibiotic eye ointment was applied on the eye, and the eye was covered with a patch at the end of the surgery.
 Procedure: bandage contact lens
bandage contact lens


Outcome Measures
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Primary Outcome Measures :
  1. patient comfort [ Time Frame: 1 week ]
    VAS scores, (0: lowest; 10: highest)

  2. patient comfort [ Time Frame: 1 week ]
    TBUT score, (the minimum score was 0, and the maximum score was 15)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554329


Locations
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Turkey
Haydarpasa Numune Education and Research Hospital
Istanbul, Marmara, Turkey, 34668
Sponsors and Collaborators
Haydarpasa Numune Training and Research Hospital
More Information
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Responsible Party: Mehmet Serhat Mangan, Medical Doctor, Haydarpasa Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04554329    
Other Study ID Numbers: HNEAH-KAEK 2019/116
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Serhat Mangan, Haydarpasa Numune Training and Research Hospital:
patient comfort
Additional relevant MeSH terms:
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Eyelid Diseases
Eye Diseases