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

Efficacy of Bandage Contact Lenses Versus Eye Patching in Early Postoperative Period of Müller's Muscle-conjunctival Resection

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 Overview

• Status: Completed
• Conditions: Eyelid Diseases
• Intervention / Treatment: Procedure: bandage contact lens

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Marmara
    • Istanbul, Marmara, Turkey, 34668
      • Haydarpasa Numune Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient comfort	VAS scores, (0: lowest; 10: highest)	1 week
patient comfort	TBUT score, (the minimum score was 0, and the maximum score was 15)	1 week

Collaborators and Investigators

• Sponsor: Haydarpasa Numune Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2017
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: September 13, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 18, 2020
• Last Update Submitted That Met QC Criteria: September 13, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: patient comfort
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases
• Other Study ID Numbers: HNEAH-KAEK 2019/116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No