Eye DisordersNCT06985264

Dry Eye in Upper Eyelid Surgery: Muscle Versus Fat Removal

A study testing Upper Eyelid Blepharoplasty surgery in people with Eye Disorders, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Eye Disorders
What is being tested?: Upper Eyelid Blepharoplasty surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 May 2025to 30 Dec 2025
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site

Mersin City Education and Research Hospital
Mersin, Çukurova, 33000

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Orbicularis Oculi and Fat Excision on Dry Eye in Upper Blepharoplasty: A Comparative Evaluation

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
Being tested: Upper Eyelid Blepharoplasty surgery
Medical subject headings: Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Upper Eyelid Blepharoplasty surgeryProcedure or surgery
Orbicularis oculi excision

Study groups in NCT06985264
Study group	Role	What they receive
1) Patients who are currently undergoing Upper Eyelid Blepharoplasty 2) Patients between the ages o	Experimental	Not described Receives: Procedure: Upper Eyelid Blepharoplasty surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202530 Dec 2025

First posted22 May 2025
Study start1 May 2025
Primary completion1 Sep 2025 (estimated)
Study completion30 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Eye DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 142 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06985264
Sponsor's protocol ID: MEŞEH
Status last verified: May 2025
First submitted: 14 May 2025
Last updated: 22 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to restrictions their containing information that could compromise the privacy of research participants.

Publications

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.
PubMed 19013787
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.
PubMed 10815152

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke

All Eye Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Orbicularis Oculi and Fat Excision on Dry Eye in Upper Blepharoplasty: A Comparative Evaluation
ClinicalTrials.gov ID: NCT06985264
Acronym / sponsor ID: MEŞEH
Conditions: Eye Disorders
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 142 participants (estimated)
Lead sponsor: Mersin Training and Research HospitalOther government
Study start: 1 May 2025 (actual)
Primary completion: 1 Sep 2025 (estimated)
Study completion: 30 Dec 2025 (estimated)
First posted: 22 May 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1) Patients who are currently undergoing Upper Eyelid Blepharoplasty 2) Patients between the ages o	Experimental	Procedure: Upper Eyelid Blepharoplasty surgery

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Upper Eyelid Blepharoplasty surgeryOrbicularis oculi excision	Procedure or surgery	1) Patients who are currently undergoing Upper Eyelid Blepharoplasty 2) Patients between the ages o

Primary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Results publication: PubMed 19013787Bottomley 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.
Results publication: PubMed 10815152Schiffman 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.
Individual participant dataSharing planned: No. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to restrictions their containing information that could compromise the privacy of research participants.

Related trials for Eye Disorders

Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Upper Eyelid Blepharoplasty surgery in people with Eye Disorders, run by Mersin Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular Surface Disease Index (OSDI) (time frame: Preoperative, postoperative 1st month, 3rd month and 6th month Ocular Surface Disease Index (OSDI) score survey will be conducted.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06985264, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.