Clinical trial NCT06985264: Dry Eye in Upper Eyelid Surgery: Muscle Versus Fat Removal
Official title: Effects of Orbicularis Oculi and Fat Excision on Dry Eye in Upper Blepharoplasty: A Comparative Evaluation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Eye Disorders
Lead sponsor: Mersin Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-22
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&lt;0.05 will be considered significant. These analyses will be performed to determine the effect of surgical techniques on dry eye symptoms.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Preoperative, postoperative 1st month, 3rd month and 6th month Ocular Surface Disease Index (OSDI) score survey will be conducted.
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin City Education and Research Hospital
state: Çukurova
Study officials:
References:
citation: 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.
citation: 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.