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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04554329
Other study ID # HNEAH-KAEK 2019/116
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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