NCT04554329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

2.5 years

First QC Date

August 7, 2020

Last Update Submit

September 13, 2020

Conditions

Eyelid Diseases

Keywords

patient comfort

Outcome Measures

Primary Outcomes (2)

  • patient comfort

    VAS scores, (0: lowest; 10: highest)

    1 week

  • patient comfort

    TBUT score, (the minimum score was 0, and the maximum score was 15)

    1 week

Study Arms (2)

bandage contact lens

ACTIVE COMPARATOR

A bandage contact lens was applied on the eye at the end of the surgery, and the eye was not covered with a patch.

Procedure: bandage contact lens

eye patching

ACTIVE COMPARATOR

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

Procedure: bandage contact lens

Interventions

bandage contact lensPROCEDURE

bandage contact lens

bandage contact lenseye patching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had unilateral ptosis and underwent unilateral MMCR

You may not qualify if:

  • Patients were excluded if they had previous eyelid surgery or had another known eye disease, such as ocular surface disorders, dry eye syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydarpasa Numune Education and Research Hospital

Istanbul, Marmara, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Eyelid Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 7, 2020

First Posted

September 18, 2020

Study Start

January 30, 2017

Primary Completion

July 30, 2019

Study Completion

August 30, 2019

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

TU(1)