Dry Eye in Upper Eyelid Surgery: Muscle Versus Fat Removal

NCT06985264 | Enrolling By Invitation

• 1 other identifier: MEŞEH
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of two different surgical techniques (Orbicularis Oculi excision and Orbicularis Oculi + Fat excision) applied in upper blepharoplasty surgery on dry eye and to evaluate the effects of these techniques on ocular surface health. 142 patients (71 patients in each group) who met the inclusion and exclusion criteria between 01.05.2025 and 31.12.2025 in Mersin City Education and Research Hospital Eye Diseases Clinic will be included in this study. This study is a prospective, survey study and aims to evaluate the effects of two different surgical techniques (Orbicularis Oculi excision only and Orbicularis Oculi + Fat excision) applied in upper blepharoplasty surgery on postoperative dry eye symptoms. The study will be conducted on patients who are currently scheduled for upper blepharoplasty surgery and no additional surgical procedures or interventions will be applied to the patients. Data collection will be done by a survey study and retrospective recording of routine clinical examinations. The collected data will be used to analyze the differences in dry eye parameters between the two surgical techniques. OSDI scores, BUT times, Oxford staining degrees, Schirmer test results and visual acuity values will be compared at pre- and postoperative time points. Differences between groups will be analyzed by one-tailed independent samples t-test and p\<0.05 will be considered significant. These analyses will be performed to determine the effect of surgical techniques on dry eye symptoms.

Conditions

Eye Disorders

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI)

  The OSDI, which was created by the Outcomes Research Group at Allergan Inc in order to quickly assess the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.

  Preoperative, postoperative 1st month, 3rd month and 6th month Ocular Surface Disease Index (OSDI) score survey will be conducted.

Study Arms (1)

1) Patients who are currently undergoing Upper Eyelid Blepharoplasty 2) Patients between the ages o

EXPERIMENTAL

Procedure: Upper Eyelid Blepharoplasty surgery

Interventions

Upper Eyelid Blepharoplasty surgery PROCEDURE

Orbicularis oculi excision

1) Patients who are currently undergoing Upper Eyelid Blepharoplasty 2) Patients between the ages o

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are currently undergoing Upper Eyelid Blepharoplasty
• Patients between the ages of 18-80
• Patients with a 6-month postoperative follow-up
• Patients without a preoperative dry eye diagnosis
• Patients who have not had previous eyelid surgery
• Those who signed the Informed Consent Form/Written Consent Form
• Patients with complete treatment and follow-up files

You may not qualify if:

• Being under 18 and over 80
• Having a history of previous eyelid surgery
• Diabetics
• Having diseases that cause dry eyes such as Sjögren, Systemic Lupus Erythematosus
• Having dry eye disease before surgery

Sponsors & Collaborators

• Mersin Training and Research Hospital: lead

Study Sites (1)

Mersin City Education and Research Hospital

Mersin, Çukurova, 33000, Turkey (Türkiye)

Location

Related Publications (2)

• Bottomley A, Jones D, Claassens L. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer. 2009 Feb;45(3):347-53. doi: 10.1016/j.ejca.2008.09.032. Epub 2008 Nov 14.

  PMID: 19013787 BACKGROUND

• Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.

  PMID: 10815152 BACKGROUND

MeSH Terms

Conditions

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 30, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)