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

M

Marmara University

Status

Completed

Conditions

Dermatochalasis of Eyelid
Dry Eye
Meibomian Gland Dysfunction
Ocular Surface Disease
Brow Ptosis

Treatments

Procedure: Upper Eyelid Blepharoplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT05528016
09.2022.102

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 2 patient groups

Skin-Only Blepharoplasty
Active Comparator group
Description:
Only the skin excision was performed for upper eyelid dermatochalasis.
Treatment:
Procedure: Upper Eyelid Blepharoplasty
Skin+Muscle Blepharoplasty
Active Comparator group
Description:
Skin plus muscle excision was performed for upper eyelid dermatochalasis.
Treatment:
Procedure: Upper Eyelid Blepharoplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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