Wrinkle AppearanceNCT07481695
Retrospective Follow-up Study on Lower Eyelid Melanin and Wrinkles After Blepharoplasty for Lower Eyelid Bags
An observational study of Wrinkle Appearance and Melanin Hyperpigmentation, run by Peking Union Medical College at 1 site in China.
Trial summary
This observational study aims to investigate the long-term outcomes of transconjunctival lower eyelid blepharoplasty, with a specific focus on changes in lower eyelid hyperpigmentation or hypopigmentation and morphological alterations of wrinkles at short-term and long-term postoperative time points. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle Appearance, Melanin Hyperpigmentation
- What is being tested?
- transconjunctival lower blepharoplasty and POD lifting
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consisted of patients aged over 35 years, with prominent lower eyelid bags and accompanying tear trough deformities. Due to concerns regarding surgical scarring, all patients underwent transconjunctival lower blepharoplasty rather than a transcutaneous approach.
Inclusion Criteria Lower eyelid bags Tear trough deformity Fear of surgical scars, refusal of transcutaneous lower blepharoplasty, and strong preference for transconjunctival approach Age older than 35 years Exclusion Criteria Previous lower eyelid surgery History of periorbital injections including hyaluronic acid, botulinum toxin, or other regenerative fillers Orbital or eyelid tumors Local infection Psychiatric disorders Lack of follow-up photographs
Trial locations and contacts
1 site in 1 country.
About this study
This observational study aims to investigate the long-term outcomes of transconjunctival lower eyelid blepharoplasty, with a specific focus on changes in lower eyelid hyperpigmentation or hypopigmentation and morphological alterations of wrinkles at short-term and long-term postoperative time points. It further seeks to clarify the overall impact of this surgical approach on lower eyelid skin appearance.
The study addresses the following research questions:
Does transconjunctival lower eyelid blepharoplasty improve lower eyelid pigmentation? If so, to what extent is the improvement achieved? Does transconjunctival lower eyelid blepharoplasty exacerbate lower eyelid wrinkles? What adjunctive or combined surgical techniques may mitigate this effect? All study participants had previously undergone transconjunctival lower eyelid blepharoplasty for the purpose of periorbital rejuvenation.
- Conditions
- Wrinkle Appearance, Melanin Hyperpigmentation
- Being tested
- transconjunctival lower blepharoplasty, POD lifting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transconjunctival lower blepharoplastyProcedure or surgery
Transconjunctival lower blepharoplasty is a minimally invasive surgical technique for lower eyelid rejuvenation. It accesses orbital fat through an internal conjunctival incision, avoiding external skin scars. It reduces fat prolapse, improves tear trough deformity, and preserves lower eyelid support, ideal for patients with prominent fat bags and minimal skin laxity.
POD liftingProcedure or surgery
POD lifting is a minimally invasive facial lifting procedure using absorbable polydioxanone sutures. It elevates sagging soft tissues by creating mechanical support and stimulating collagen production.
| Study group | Role | What they receive |
|---|---|---|
| Transconjunctival lower blepharoplasty | conventional transconjunctival lower blepharoplasty, this conventional approach combined of transconjunctival intraorbital fat excision and fat transplantation. Receives: Procedure: transconjunctival lower blepharoplasty | |
| Transconjunctival lower blepharoplasty combined with POD lifting | conventional transconjunctival lower blepharoplasty combined POD lifting in order to alleviate postoperative skin laxity. Receives: Procedure: transconjunctival lower blepharoplasty; Procedure: POD lifting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barton's grading scale
The Barton Grading Scale is a validated clinical tool standardized for assessing the severity of lower eyelid contour deformities, particularly tear troughs and lower eyelid bags. It operates on a numeric or alphanumeric scale, typically ranging from 0 to 4 or Grade I to III, to quantify the depth of the tear trough and the degree of orbital fat prolapse.
Measured: Before the operation, and six months after the operation
Global Aesthetic Improvement Scale
Global Aesthetic Improvement Scale (GAIS) is a validated 5-point subjective scale used to evaluate overall facial aesthetic improvement from baseline, widely applied in clinical trials and skincare research. Raters (clinicians or participants) score from 1 (markedly improved) to 5 (much worse), often with a neutral midpoint. It complements objective measures by assessing holistic changes in wrinkles, skin laxity, tone, and texture. Standardized training ensures inter-rater reliability. GAIS is integral to quantifying treatment effects in periorbital rejuvenation and anti-aging studies, providing actionable global outcomes.
Measured: Before the operation, and six months after the operation
Periorbital hyperpigmentation assessment
Periorbital hyperpigmentation assessment includes both qualitative and quantitative evaluation. Qualitative assessment uses a 5-point scale: 0 = matched facial skin color; 1 = mild periorbital pigmentation; 2 = obvious pigmentation; 3 = severe dark color involving upper and lower eyelids; 4 = severe pigmentation extending beyond the infraorbital fold. Quantitative assessment compares pre- and postoperative grayscale values derived from standardized clinical photographs.
Measured: Before the operation and six months after the operation
Wrinkles in the lower eyelid
Wrinkles in the lower eyelid are evaluated using a quantitative method. The number and length of lower eyelid wrinkles are measured and calculated. Preoperative and postoperative changes are objectively compared to assess the surgical effect on wrinkle improvement.
Measured: Before the operation and six months after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Feb 2021
- Primary completion1 Sep 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkle AppearanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaolei Jin, The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481695
- Sponsor's protocol ID
- 2026（084）
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Follow-up Study on Lower Eyelid Melanin and Wrinkles After Blepharoplasty for Lower Eyelid Bags
- ClinicalTrials.gov ID
- NCT07481695
- Acronym / sponsor ID
- 2026（084）
- Conditions
- Wrinkle Appearance, Melanin Hyperpigmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 19 Mar 2026 (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 observational study aims to investigate the long-term outcomes of transconjunctival lower eyelid blepharoplasty, with a specific focus on changes in lower eyelid hyperpigmentation or hypopigmentation and morphological alterations of wrinkles at short-term and long-term postoperative time points. It further seeks to clarify the overall impact of this surgical approach on lower eyelid skin appearance.
The study addresses the following research questions:
Does transconjunctival lower eyelid blepharoplasty improve lower eyelid pigmentation? If so, to what extent is the improvement achieved? Does transconjunctival lower eyelid blepharoplasty exacerbate lower eyelid wrinkles? What adjunctive or combined surgical techniques may mitigate this effect? All study participants had previously undergone transconjunctival lower eyelid blepharoplasty for the purpose of periorbital rejuvenation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transconjunctival lower blepharoplasty | – | Procedure: transconjunctival lower blepharoplastyconventional transconjunctival lower blepharoplasty, this conventional approach combined of transconjunctival intraorbital fat excision and fat transplantation. |
| Transconjunctival lower blepharoplasty combined with POD lifting | – | Procedure: transconjunctival lower blepharoplasty, Procedure: POD liftingconventional transconjunctival lower blepharoplasty combined POD lifting in order to alleviate postoperative skin laxity. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of patients aged over 35 years, with prominent lower eyelid bags and accompanying tear trough deformities. Due to concerns regarding surgical scarring, all patients underwent transconjunctival lower blepharoplasty rather than a transcutaneous approach.
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 |
|---|---|---|
| transconjunctival lower blepharoplastyTransconjunctival lower blepharoplasty is a minimally invasive surgical technique for lower eyelid rejuvenation. It accesses orbital fat through an internal conjunctival incision, avoiding external skin scars. It reduces fat prolapse, improves tear trough deformity, and preserves lower eyelid support, ideal for patients with prominent fat bags and minimal skin laxity. | Procedure or surgery | Transconjunctival lower blepharoplasty, Transconjunctival lower blepharoplasty combined with POD lifting |
| POD liftingPOD lifting is a minimally invasive facial lifting procedure using absorbable polydioxanone sutures. It elevates sagging soft tissues by creating mechanical support and stimulating collagen production. | Procedure or surgery | Transconjunctival lower blepharoplasty combined with POD lifting |
Primary outcome
Barton's grading scale
Time frame: Before the operation, and six months after the operation
The Barton Grading Scale is a validated clinical tool standardized for assessing the severity of lower eyelid contour deformities, particularly tear troughs and lower eyelid bags. It operates on a numeric or alphanumeric scale, typically ranging from 0 to 4 or Grade I to III, to quantify the depth of the tear trough and the degree of orbital fat prolapse.
Global Aesthetic Improvement Scale
Time frame: Before the operation, and six months after the operation
Global Aesthetic Improvement Scale (GAIS) is a validated 5-point subjective scale used to evaluate overall facial aesthetic improvement from baseline, widely applied in clinical trials and skincare research. Raters (clinicians or participants) score from 1 (markedly improved) to 5 (much worse), often with a neutral midpoint. It complements objective measures by assessing holistic changes in wrinkles, skin laxity, tone, and texture. Standardized training ensures inter-rater reliability. GAIS is integral to quantifying treatment effects in periorbital rejuvenation and anti-aging studies, providing actionable global outcomes.
Periorbital hyperpigmentation assessment
Time frame: Before the operation and six months after the operation
Periorbital hyperpigmentation assessment includes both qualitative and quantitative evaluation. Qualitative assessment uses a 5-point scale: 0 = matched facial skin color; 1 = mild periorbital pigmentation; 2 = obvious pigmentation; 3 = severe dark color involving upper and lower eyelids; 4 = severe pigmentation extending beyond the infraorbital fold. Quantitative assessment compares pre- and postoperative grayscale values derived from standardized clinical photographs.
Wrinkles in the lower eyelid
Time frame: Before the operation and six months after the operation.
Wrinkles in the lower eyelid are evaluated using a quantitative method. The number and length of lower eyelid wrinkles are measured and calculated. Preoperative and postoperative changes are objectively compared to assess the surgical effect on wrinkle improvement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- 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. This study is not recruiting at the moment.
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?
An observational study of Wrinkle Appearance and Melanin Hyperpigmentation, run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 Mar 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Barton's grading scale (time frame: Before the operation, and six months after the operation). The study lists 4 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 19 Mar 2026.