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

Not Applicable

Completed

• Conditions: Eyelid Diseases
• Interventions: Procedure: bandage contact lens

• Registration Number: NCT04554329
• Lead Sponsor: Haydarpasa Numune Training and Research Hospital

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.

Study Timeline

• Study Start: 2017-01-30
• Primary Completion: 2019-07-30
• Study Completion: 2019-08-30
• Study First Submitted: 2020-08-07
• Status Verified: 2020-09
• Study First Submitted QC: 2020-09-13
• Last Update Submitted: 2020-09-13
• Study First Posted: 2020-09-18
• Last Update Posted: 2020-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bandage contact lens	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.
eye patching	bandage contact lens	Antibiotic eye ointment was applied on the eye, and the eye was covered with a patch at the end of the surgery.

Primary Outcome Measures

Name	Time	Method
patient comfort	1 week	TBUT score, (the minimum score was 0, and the maximum score was 15)

Trial Locations

Locations (1)

Haydarpasa Numune Education and Research Hospital; 🇹🇷 Istanbul, Marmara, Turkey