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Completed

NCT Number: NCT04554329

Bandage Contact Lenses Versus Eye Patching 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.

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Key information

Conditions

Eyelid Diseases Eye Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydarpasa Numune Education and Research Hospital

Istanbul, Marmara, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bandage contact lens

Procedure

bandage contact lens

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2020
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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