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NCT Number: NCT05528016

Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty

This study aims to evaluate the short and long-term effects of skin-only and skin+muscle excision blepharoplasty on corneal nerves, dry eye parameters, meibomian glands, and eyebrow position.

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Key information

Conditions

Dermatochalasis of Eyelid Brow Ptosis Dry Eye Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases Meibomian Gland Dysfunction Ocular Surface Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Pendik Research and Educational Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

About this study

The study was designed with the approval of the Ethics Committee on Human Research of Marmara University and was conducted following the tenets of the Declaration of Helsinki. Written informed consent was obtained from all patients who received information about the procedure and the postoperative course. The study included 48 eyes of 24 patients older than 18 who applied to Marmara University Oculoplastic and Orbital Surgery Unit due to dermatochalasis and were suggested upper eyelid blepharoplasty for medical or cosmetic purposes. The patients were divided into two groups, Group S (n=12) for skin excision only and Group M (n=12) for skin+muscle excision by the decision of the surgeon. In addition to all ophthalmological examinations, sub-basal nerve plexus parameters with corneal confocal microscopy, Schirmer I test, non-invasive tear break-up time, meibomian gland area loss measurements with infrared meibography, central eyebrow height, and lateral eyebrow height were evaluated at baseline and postoperative 1st week, 1st month and 1st-year follow-ups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18.
  • Patients with dermatochalasis.
  • Patients who were suggested upper eyelid blepharoplasty for medical or cosmetic purposes.

Exclusion criteria

  • Patients who have had previous periorbital or ophthalmic surgery
  • Patients with extensive blepharitis
  • History of contact lens use
  • History of ophthalmic, endocrinological, neurological, or rheumatological diseases
  • History of facial paralysis
  • Negative Bell's phenomenon
  • Schirmer test <5mm
  • The patients who had been treated with periocular botulinum toxin in the last 1 year were not included the study.

Treatment and study plan

Upper Eyelid Blepharoplasty

Procedure

Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.

Primary outcomes

  1. Corneal nerve fiber density (CNFD)

    Time frame: Baseline / 1 Week / 1 Month / 1 Year

    Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNFD in fibers/mm2

  2. Corneal nerve branch density (CNBD)

    Time frame: Baseline / 1 Week / 1 Month / 1 Year

    Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in branches/mm2.

  3. Corneal nerve fiber length (CNFL)

    Time frame: Baseline / 1 Week / 1 Month / 1 Year

    Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in mm/mm2.

  4. Eyebrow position

    Time frame: Baseline / 1 Week / 1 Month / 1 Year

    Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.

  5. Meibomian Gland Area Loss (MGAL)

    Time frame: Baseline / 1 Week / 1 Month / 1 Year

    Phoenix-Meibography Imaging software that is available in the Sirius® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate meibomian gland area loss in percentage.

  6. Non-invasive Tear Break-Up Time (NI-BUT)

    Time frame: Baseline / 1 Week / 1 Month / 1 Year

    Phoenix-Meibography Imaging software that is available in the Sirius® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate non-invasive tear break-up time in seconds.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Elaborated Analysis of Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty on Corneal Nerves, Meibomian Glands, Dry Eye Parameters, and Eyebrow Position

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 6, 2022
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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