Dermatochalasis of Upper EyelidNCT07250139
Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
A study testing Ziplyft Device and Comparator Arm: Standard Blepharoplasty in people with Dermatochalasis of Upper Eyelid and Ptosis, Eyelid, run by Osheru Inc. at 1 site in United States.
Trial summary
This study will compare two surgery techniques used for upper eyelid (eyelift) surgery: traditional surgery and a newer method called Ziplyft (a non-powered, hand-held clamp). This study will use a "split-face" design, meaning one eyelid will be treated with the traditional surgery method and the other with Ziplyft… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Dermatochalasis of Upper Eyelid, Ptosis, Eyelid, Blepharoplasty
- What is being tested?
- Ziplyft Device and Comparator Arm: Standard Blepharoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to 30 Sep 2026
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed written consent prior to participation in any study-related procedures.
- Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
- Male or female adults, ≥ 35 years old at the Preoperative Visit willing to return for required follow-up visits.
- Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
- Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
Who cannot join
- Subjects with a current Ptosis diagnosis
- Subjects with a history of Graves' Disease
- Subjects with Myasthenia Gravis
- Subjects that in the opinion of the investigator are anatomically not conducive to using devices (e.g., heavy brow, severe hollowing of the upper eyelid, history of ocular or orbital trauma).
- Subjects that have had any previous surgery eyelid or eyebrow region.
- Use of anticoagulation therapy, including, but not limited to Aspirin, NSAIDS, Ibuprofen within 7 days and Xarelto, Warfarin, Enoxaparin, Plavix within 3 days prior to planned study procedure.
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- Active or recent (within 3 months) tobacco user
- Allergy to adhesive glue
- Participation in any study of an investigational, interventional product within 30 days prior to the Preoperative Visit or at any time during the study period.
- Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New Century Ophthalmology
Oxford, North Carolina, 27585
Sumeet Jindal, MD, MBA, 919-375-2259, thesumeetjindal@gmail.com
Sumeet Jindal, MD
About this study
This study will compare two surgery techniques used for upper eyelid (eyelift) surgery: traditional surgery and a newer method called Ziplyft (a non-powered, hand-held clamp). This study will use a "split-face" design, meaning one eyelid will be treated with the traditional surgery method and the other with Ziplyft, allowing a direct side-by-side comparison.
The objectives of the study are to compare Ziplyft treatment vs. traditional surgery by evaluating bruising, wound closure and incision, surgery case time, and subject/surgeon surveys.
Read the detailed description
Blepharoplasty (upper eyelid surgery), is a procedure where excess upper eyelid skin that can interfere with peripheral vision is removed, resulting in improvement in peripheral vision and a more revitalized appearance. The amount of excess skin to be removed from each lid is marked symmetrically on both right and left sides just as it is in a standard blepharoplasty. The difference in this comparative study is that one side will be done using a blade, cautery to seal blood vessels, and sutures to close the incision which is how a standard blepharoplasty procedure is performed. On the other side, the exact same amount of tissue that was marked prior to the surgery will be removed. The fellow (second) side will use a clamp (Ziplyft) to compress the excess skin prior to removal so that there is no bleeding and therefore no need for cautery to seal blood vessels. The same amount of tissue will be removed on this second side; it will be all the marked tissue. As the clamp compresses the excess skin and seals it together, no suturing is required, and the incision can be closed with tissue adhesive which has been used for many years to close eyelid surgery incisions. Using the commercially available tissue adhesive eliminates the need for sutures to close the incision. Both right and left upper eyelids will have the same amount of tissue removed, similar to standard blepharoplasty surgery. Both sides will also have incisions; one will be closed with sutures, and the other will be closed with tissue adhesive. In summary, both right and left upper eyelids are getting a standard blepharoplasty procedure. One side is utilizing a clamp (Ziplyft) to eliminate bleeding and the need for sutures.
The surgeon will record case time for Ziplyft side and traditional blepharoplasty side. Post-op photos taken at day 3 and 7 will be used to assess ecchymosis (bruising) by a masked, independent professional (physician). Photos taken at 7 days and 1-month post-op with lids closed and lids open will be rated on incision appearance by a masked, independent professional (physician). Participant- and surgeon-reported surveys will be used to evaluate satisfaction with the Ziplyft procedure and outcome.
- Being tested
- Ziplyft Device, Comparator Arm: Standard Blepharoplasty
- Keywords
- Dermatochalasis of upper eyelid, Ptosis of upper eyelid, blepharoplasty,, Ziplyft, upper eyelid surgery
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziplyft DeviceDevice
Ziplyft will be used on one side of the participant's face to compress the excess skin prior to excess eyelid skin removal. Ziplyft compresses the excess skin and seals it together, no suturing is required, and the surgery incision will be closed with tissue adhesive.
Comparator Arm: Standard BlepharoplastyOther
Standard blepharoplasty will be used on the fellow side of the participant's face. Standard blepharoplasty uses a blade, cautery to seal blood vessels, and sutures to close the incision.
| Study group | Role | What they receive |
|---|---|---|
| Comparing Ziplyft Device Treatment to Standard Blepharoplasty | Experimental | Ziplyft is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin. Ziplyft will be used on one side of the participant's face to compress the excess skin prior to excess eyelid skin removal.
Standard blepharoplasty will be performed on the fellow side of the participant's face. Receives: Device: Ziplyft Device; Other: Comparator Arm: Standard Blepharoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare surgical case time for Ziplyft treatment versus standard blepharoplasty
The surgeon will record the surgical case times for Ziplyft and standard blepharoplasty. For the Ziplyft side of the participant's face the surgical case time begins when the Ziplyft device touches the patient lid and ends 1 min after adhesive is applied as that is when it has cured. For the standard blepharoplasty side of the participant's face the surgical case time begins as the blade begins its first cut and ends once ointment has been applied.
Measured: From the beginning of the surgical case until surgery has been completed
Document post-operative ecchymosis with Ziplyft and standard blepharoplasty
Ecchymosis will be measured by post-operative photographs taken at day 3 and day 7. Photos will be rated on a 1-4 scale for ecchymosis by an independent masked observer (physician).
Measured: 3 days following surgery (±1 day) to 9 days after the surgery (± 3 days)
Measure the success of tissue adhesive (Ziplyft side) versus suture (standard blepharoplasty side) for wound closure and incision appearance.
Photos taken at 9 days and 1-month post-op with lids closed and lids open will be rated on incision appearance by an independent masked observer (physician).
Measured: 9 days (± 3 days) to up to 2 months (± 1 month) post-operation
Assess patient reported outcomes with Ziplyft versus standard blepharoplasty
Patient satisfaction questionnaires regarding comfort, satisfaction, and healing experience will be administered to the participants on the day of surgery and at 2 months post operation.
Measured: After the surgery is completed (post-operation on the day of the procedure) until 2 months (± 1 month) post operation
Evaluate surgeon-reported experiences with Ziplyft and standard blepharoplasty
A surgeon-reported questionnaire regarding the procedure efficiency, bleeding, and the use of cautery and suture will be administered following the surgical procedure. A second surgeon-reported questionnaire regarding the use of adhesive, bruising, swelling, scaring, and symmetry will be administered at 2-months post operation.
Measured: The day of surgery until 2 months (± 1 month) post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start8 Dec 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatochalasis of Upper EyelidStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study will be conducted using a "split-face" design. For each participant, one eyelid will be treated with the traditional blepharoplasty method and the other with Ziplyft, allowing a direct side-by-side comparison.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osheru Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250139
- Sponsor's protocol ID
- 25592-Osheru
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
- ClinicalTrials.gov ID
- NCT07250139
- Acronym / sponsor ID
- 25592-Osheru
- Keywords
- Dermatochalasis of upper eyelid, Ptosis of upper eyelid, blepharoplasty,, Ziplyft, upper eyelid surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Osheru Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 26 Nov 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.
This study will compare two surgery techniques used for upper eyelid (eyelift) surgery: traditional surgery and a newer method called Ziplyft (a non-powered, hand-held clamp). This study will use a "split-face" design, meaning one eyelid will be treated with the traditional surgery method and the other with Ziplyft, allowing a direct side-by-side comparison.
The objectives of the study are to compare Ziplyft treatment vs. traditional surgery by evaluating bruising, wound closure and incision, surgery case time, and subject/surgeon surveys.
Detailed description
Blepharoplasty (upper eyelid surgery), is a procedure where excess upper eyelid skin that can interfere with peripheral vision is removed, resulting in improvement in peripheral vision and a more revitalized appearance. The amount of excess skin to be removed from each lid is marked symmetrically on both right and left sides just as it is in a standard blepharoplasty. The difference in this comparative study is that one side will be done using a blade, cautery to seal blood vessels, and sutures to close the incision which is how a standard blepharoplasty procedure is performed. On the other side, the exact same amount of tissue that was marked prior to the surgery will be removed. The fellow (second) side will use a clamp (Ziplyft) to compress the excess skin prior to removal so that there is no bleeding and therefore no need for cautery to seal blood vessels. The same amount of tissue will be removed on this second side; it will be all the marked tissue. As the clamp compresses the excess skin and seals it together, no suturing is required, and the incision can be closed with tissue adhesive which has been used for many years to close eyelid surgery incisions. Using the commercially available tissue adhesive eliminates the need for sutures to close the incision. Both right and left upper eyelids will have the same amount of tissue removed, similar to standard blepharoplasty surgery. Both sides will also have incisions; one will be closed with sutures, and the other will be closed with tissue adhesive. In summary, both right and left upper eyelids are getting a standard blepharoplasty procedure. One side is utilizing a clamp (Ziplyft) to eliminate bleeding and the need for sutures.
The surgeon will record case time for Ziplyft side and traditional blepharoplasty side. Post-op photos taken at day 3 and 7 will be used to assess ecchymosis (bruising) by a masked, independent professional (physician). Photos taken at 7 days and 1-month post-op with lids closed and lids open will be rated on incision appearance by a masked, independent professional (physician). Participant- and surgeon-reported surveys will be used to evaluate satisfaction with the Ziplyft procedure and outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will be conducted using a "split-face" design. For each participant, one eyelid will be treated with the traditional blepharoplasty method and the other with Ziplyft, allowing a direct side-by-side comparison.
| Arm | Type | Receives |
|---|---|---|
| Comparing Ziplyft Device Treatment to Standard Blepharoplasty | Experimental | Device: Ziplyft Device, Other: Comparator Arm: Standard BlepharoplastyZiplyft is a Class 1, 510(k) Exempt device for removing excess unwanted eyelid skin. Ziplyft will be used on one side of the participant's face to compress the excess skin prior to excess eyelid skin removal. Standard blepharoplasty will be performed on the fellow side of the participant's face. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide signed written consent prior to participation in any study-related procedures.
- Ability, comprehension, and willingness to follow study instructions, and likely to complete all study visits.
- Male or female adults, ≥ 35 years old at the Preoperative Visit willing to return for required follow-up visits.
- Subjects with excess eyelid skin are eligible to undergo the procedure in the opinion of the investigator.
- Female subjects must be 1-year postmenopausal, surgically sterilized, or, if of childbearing potential, have a negative urine pregnancy test at the Preoperative Visit. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
Key exclusion criteria (10 listed)
- Subjects with a current Ptosis diagnosis
- Subjects with a history of Graves' Disease
- Subjects with Myasthenia Gravis
- Subjects that in the opinion of the investigator are anatomically not conducive to using devices (e.g., heavy brow, severe hollowing of the upper eyelid, history of ocular or orbital trauma).
- Subjects that have had any previous surgery eyelid or eyebrow region.
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 |
|---|---|---|
| Ziplyft DeviceZiplyft will be used on one side of the participant's face to compress the excess skin prior to excess eyelid skin removal. Ziplyft compresses the excess skin and seals it together, no suturing is required, and the surgery incision will be closed with tissue adhesive. | Device | Comparing Ziplyft Device Treatment to Standard Blepharoplasty |
| Comparator Arm: Standard BlepharoplastyStandard blepharoplasty will be used on the fellow side of the participant's face. Standard blepharoplasty uses a blade, cautery to seal blood vessels, and sutures to close the incision. | Other | Comparing Ziplyft Device Treatment to Standard Blepharoplasty |
Primary outcome
Compare surgical case time for Ziplyft treatment versus standard blepharoplasty
Time frame: From the beginning of the surgical case until surgery has been completed
The surgeon will record the surgical case times for Ziplyft and standard blepharoplasty. For the Ziplyft side of the participant's face the surgical case time begins when the Ziplyft device touches the patient lid and ends 1 min after adhesive is applied as that is when it has cured. For the standard blepharoplasty side of the participant's face the surgical case time begins as the blade begins its first cut and ends once ointment has been applied.
Document post-operative ecchymosis with Ziplyft and standard blepharoplasty
Time frame: 3 days following surgery (±1 day) to 9 days after the surgery (± 3 days)
Ecchymosis will be measured by post-operative photographs taken at day 3 and day 7. Photos will be rated on a 1-4 scale for ecchymosis by an independent masked observer (physician).
Measure the success of tissue adhesive (Ziplyft side) versus suture (standard blepharoplasty side) for wound closure and incision appearance.
Time frame: 9 days (± 3 days) to up to 2 months (± 1 month) post-operation
Photos taken at 9 days and 1-month post-op with lids closed and lids open will be rated on incision appearance by an independent masked observer (physician).
Assess patient reported outcomes with Ziplyft versus standard blepharoplasty
Time frame: After the surgery is completed (post-operation on the day of the procedure) until 2 months (± 1 month) post operation
Patient satisfaction questionnaires regarding comfort, satisfaction, and healing experience will be administered to the participants on the day of surgery and at 2 months post operation.
Evaluate surgeon-reported experiences with Ziplyft and standard blepharoplasty
Time frame: The day of surgery until 2 months (± 1 month) post-operation
A surgeon-reported questionnaire regarding the procedure efficiency, bleeding, and the use of cautery and suture will be administered following the surgical procedure. A second surgeon-reported questionnaire regarding the use of adhesive, bruising, swelling, scaring, and symmetry will be administered at 2-months post operation.
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 26 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ziplyft Device and Comparator Arm: Standard Blepharoplasty in people with Dermatochalasis of Upper Eyelid and Ptosis, Eyelid, run by Osheru Inc. at 1 site in United States.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 26 Nov 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 United States. 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?
Contact Patricia Buehler, MD (541-419-4412, pbuehler@osheru.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare surgical case time for Ziplyft treatment versus standard blepharoplasty (time frame: From the beginning of the surgical case until surgery has been completed). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.