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CompletedNCT04554329Updated Sep 18, 2020

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

An interventional study of bandage contact lens in Eyelid Diseases, sponsored by Haydarpasa Numune Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-09-18.

Sponsored by Haydarpasa Numune Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 6 months after the study started (first participant enrolled Jan 2017, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Eyelid Diseases

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Keywords

  • patient comfort
03

In context

Eyelid Diseases

26 studies on the registry are indexed under Eyelid Diseases; 3 are open to participants now.

This study's enrollment of 40 is close to the median of 40 across 17 interventional studies indexed under Eyelid Diseases.

Browse Eyelid Diseases studies →

Lead sponsor

Haydarpasa Numune Training and Research Hospital is the lead sponsor of 32 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who had unilateral ptosis and underwent unilateral MMCR

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    bandage contact lens

    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

  • Active comparator
    eye patching

    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

  • Procedurebandage contact lens

    bandage contact lens

06

What researchers measure

Primary outcomes

  1. patient comfort

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

    Time frame: 1 week

  2. patient comfort

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

    Time frame: 1 week

07

Study locations

1 site
  • Haydarpasa Numune Education and Research Hospital
    Istanbul, Marmara 34668, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04554329
Lead sponsor
Haydarpasa Numune Training and Research Hospital
Responsible party
Mehmet Serhat Mangan (Medical Doctor, Haydarpasa Numune Training and Research Hospital) — Principal investigator
First posted
Sep 18, 2020
Start date
Jan 30, 2017
Primary completion
Jul 30, 2019
Completion
Aug 30, 2019
Last update
Sep 18, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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