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

NCT ID: NCT04554329

Last Updated: 2020-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2019-08-30

Brief Summary

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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

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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.

Conditions

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Eyelid Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

bandage contact lens

Intervention Type PROCEDURE

bandage contact lens

eye patching

Antibiotic eye ointment was applied on the eye, and the eye was covered with a patch at the end of the surgery.

Group Type ACTIVE_COMPARATOR

bandage contact lens

Intervention Type PROCEDURE

bandage contact lens

Interventions

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bandage contact lens

bandage contact lens

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Serhat Mangan

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Haydarpasa Numune Education and Research Hospital

Istanbul, Marmara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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HNEAH-KAEK 2019/116

Identifier Type: -

Identifier Source: org_study_id

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