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

Eyelid Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554329
• Other study ID #: HNEAH-KAEK 2019/116
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: September 2020
• Source: Haydarpasa Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eyelid Diseases

Intervention

Procedure:
• bandage contact lens
bandage contact lens

Locations

Country	Name	City	State
Turkey	Haydarpasa Numune Education and Research Hospital	Istanbul	Marmara

Sponsors (1)

Lead Sponsor	Collaborator
Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient comfort	VAS scores, (0: lowest; 10: highest)	1 week
Primary	patient comfort	TBUT score, (the minimum score was 0, and the maximum score was 15)	1 week