Bandage Contact Lenses Versus Eye Patching of Müller's Mu... | NCT04554329

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

NCT04554329

Sponsor

Haydarpasa Numune Training and Research Hospital

Status

Completed

Last Update Posted

Sep 18, 2020Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Eyelid Diseases

Interventions

bandage contact lens

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2017Actual

Primary Completion Date

Jul 30, 2019Actual

Completion Date

Aug 30, 2019Actual

First Submitted Date

Aug 7, 2020

First Submission Date that Met QC Criteria

Sep 13, 2020

First Posted Date

Sep 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2020

Last Update Posted Date

Sep 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehmet Serhat Mangan, Medical Doctor, Haydarpasa Numune Training and Research HospitalPrincipal Investigator

Lead Sponsor

Haydarpasa Numune Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
bandage contact lens	Procedure	bandage contact lens	bandage contact lens eye patching

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haydarpasa Numune Education and Research Hospital		Istanbul	Marmara	34668	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided