An interventional study of Upper Blepharoplasty and Barbed Thread Brow Suspension in Brow Ptosis, Dermatochalasis and Periorbital Aging, sponsored by Muhammed Mustafa Demirok. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Muhammed Mustafa Demirok · Not applicable, Interventional, and Treatment
This prospective clinical study aims to investigate whether combining upper blepharoplasty with limited release of the lateral brow-retaining ligaments improves the long-term effectiveness of barbed thread brow suspension.
Lateral eyebrow drooping can contribute to an aged or tired appearance around the eyes. Although thread-based brow lifting can improve eyebrow position, the lifting effect may decrease over time. The researchers aim to determine whether releasing the tissue attachments that restrict eyebrow movement can help maintain the lifting effect.
The study plans to enroll 90 adults aged 20-70 years, divided into three groups of approximately 30 participants each:
Treatment selection will be based on each participant's anatomical characteristics and clinical indications, without random assignment.
Participants will be evaluated before surgery and at 1 week and 1, 3, 6, and 12 months after surgery. Standardized photographs will be analyzed to measure changes in lateral eyebrow height. Eyebrow symmetry, complications, adverse events, and the need for revision surgery will also be assessed.
The study aims to determine whether the combined surgical approach provides more durable lateral brow elevation without increasing postoperative complications.
This is a prospective, single-center, controlled, non-randomized, three-group comparative clinical study designed to evaluate the effectiveness and safety of a hybrid surgical technique for lateral brow elevation.
**Background**
Lateral brow ptosis and age-related periorbital soft-tissue changes are common aesthetic concerns. Barbed thread suspension provides a minimally invasive method of brow elevation; however, the durability of its lifting effect may be limited by resistance from the lateral brow-retaining ligaments and surrounding soft-tissue attachments.
Limited release of these attachments through an upper blepharoplasty incision may facilitate superior mobilization of the lateral eyebrow and improve the long-term effectiveness of thread suspension.
**Study Objective**
The primary objective is to compare the durability of lateral brow elevation achieved with upper blepharoplasty-assisted lateral retaining ligament release combined with barbed thread suspension against standard barbed thread suspension alone.
Secondary objectives include assessing eyebrow symmetry, postoperative complications, adverse events, and the need for revision surgery.
**Study Population and Design**
The study will be conducted at Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul, Türkiye.
A total of 90 adults aged 20-70 years with lateral brow ptosis, eyebrow descent, or age-related periorbital soft-tissue changes are planned for enrollment.
Participants will be allocated to three treatment groups according to clinical examination findings, anatomical characteristics, and treatment requirements. No randomization will be performed.
**Treatment Groups**
Group 1: Standard Upper Blepharoplasty
Participants will undergo conventional upper blepharoplasty without an additional brow-elevating procedure.
Group 2: Standard Barbed Thread Brow Suspension
Participants will undergo lateral brow suspension using CE-marked, double-needle, barbed poly(L-lactide-co-epsilon-caprolactone) (PLACL) threads, without surgical release of the lateral retaining ligaments.
Group 3: Hybrid Brow Elevation
Participants will undergo upper blepharoplasty with limited release of the lateral retaining ligaments and associated soft-tissue attachments, followed by lateral brow suspension using barbed PLACL threads.
**Follow-up and Outcome Assessment**
All participants will undergo standardized clinical and photographic evaluations at baseline and at postoperative week 1 and months 1, 3, 6, and 12.
The primary outcome is the change in lateral eyebrow height at 12 months compared with baseline, assessed using standardized digital photogrammetry and ImageJ software.
Secondary outcomes include changes in right and left lateral brow height, eyebrow symmetry, early and late postoperative complications, treatment-related adverse events, and the requirement for revision procedures.
**Study Hypothesis**
The investigators hypothesize that limited lateral retaining ligament release combined with barbed thread suspension will provide more sustained lateral brow elevation than standard thread suspension alone, without a clinically significant increase in complications.
151 studies on the registry are indexed under Cutis Laxa; 36 are open to participants now.
This study's planned enrollment of 90 is above the median of 30 across 133 interventional studies indexed under Cutis Laxa.
Browse Cutis Laxa studies →This is the only study on the registry with Muhammed Mustafa Demirok as lead sponsor.
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**Inclusion Criteria:**
**Exclusion Criteria:**
Participants in this arm will undergo standard upper blepharoplasty without an additional brow-elevating procedure. The surgery will involve excision of excess upper eyelid skin, with management of the orbicularis oculi muscle and orbital fat when clinically indicated. No lateral retaining ligament release or barbed thread brow suspension will be performed. Approximately 30 participants are planned for this arm.
Procedure: Upper Blepharoplasty
Participants in this arm will undergo lateral brow elevation using CE-marked, double-needle, barbed poly(L-lactide-co-epsilon-caprolactone) (PLACL) suspension threads. The procedure will be performed without upper blepharoplasty or surgical release of the lateral brow-retaining ligaments. Approximately 30 participants are planned for this arm.
Procedure: Barbed Thread Brow Suspension
Participants in this arm will undergo upper blepharoplasty combined with limited release of the lateral brow-retaining ligaments and associated soft-tissue attachments through the upper eyelid incision. Lateral brow elevation will subsequently be performed using CE-marked, double-needle, barbed PLACL suspension threads. This hybrid approach aims to improve the durability of lateral brow elevation by reducing tissue resistance before thread suspension. Approximately 30 participants are planned for this arm.
Procedure: Upper Blepharoplasty · Procedure: Barbed Thread Brow Suspension · Procedure: Lateral Brow-Retaining Ligament Release
Standard upper blepharoplasty involving excision of excess upper eyelid skin, with management of the orbicularis oculi muscle and orbital fat when clinically indicated. In the hybrid treatment arm, the upper blepharoplasty incision also provides access for limited lateral brow-retaining ligament release.
Lateral brow suspension using CE-marked, double-needle, barbed poly(L-lactide-co-epsilon-caprolactone) (PLACL) threads. The threads are used to elevate and support the lateral eyebrow through fixation to the temporal fascia. The technique is performed either as a standalone brow-lifting procedure or in combination with upper blepharoplasty and lateral retaining ligament release.
Limited surgical release of the lateral brow-retaining ligaments and associated soft-tissue attachments through an upper blepharoplasty incision. The procedure is performed to facilitate superior mobilization of the lateral eyebrow and reduce tissue resistance before barbed thread suspension. This intervention is performed exclusively in the hybrid treatment arm.
Change in Lateral Brow Height From Baseline to 12 Months
Change in lateral eyebrow height from the preoperative baseline to postoperative month 12, measured using standardized clinical photographs and digital photogrammetric analysis with ImageJ software. Measurements will use consistent anatomical reference points across visits. Changes will be compared among the three treatment groups to evaluate the durability of lateral brow elevation.
Time frame: Baseline and postoperative month 12
Change in Right and Left Lateral Brow Height
Changes in right and left lateral eyebrow height relative to baseline, measured separately using standardized clinical photographs and ImageJ digital photogrammetry. Measurements will be compared across treatment groups and postoperative follow-up visits.
Time frame: Baseline; postoperative week 1 and months 1, 3, 6, and 12
Change in Eyebrow Symmetry
Change in eyebrow symmetry assessed by comparing right and left lateral brow heights on standardized clinical photographs using ImageJ software. Interbrow height differences will be evaluated at baseline and during postoperative follow-up.
Time frame: Baseline; postoperative week 1 and months 1, 3, 6, and 12
Incidence of Early and Late Postoperative Complications
Number and proportion of participants experiencing postoperative complications during the 12-month follow-up period. Early and late complications will be documented through clinical examination and follow-up assessments and compared across treatment groups.
Time frame: From surgery through postoperative month 12
Incidence of Revision Surgery
Number and proportion of participants requiring revision surgery related to the initial treatment during the 12-month postoperative follow-up period. Revision requirements will be recorded and compared across the three treatment groups.
Time frame: From surgery through postoperative month 12
Incidence of Treatment-Related Adverse Events
Number and proportion of participants experiencing treatment-related adverse events during the 12-month follow-up period. Events will be recorded through postoperative clinical assessments, including their nature and relationship to the surgical intervention.
Time frame: From surgery through postoperative month 12
Plan to share: No — Individual participant data will not be shared because the study involves sensitive clinical information and standardized facial photographs that may pose a risk of participant identification. Data will be maintained confidentially in accordance with the approved study protocol, informed consent, and applicable data protection regulations. Aggregated and de-identified study results will be reported in scientific publications.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2028, 15 months later.
Of 77 interventional studies with no phase under Cutis Laxa, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 20. This study's planned 15 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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