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Completed

NCT Number: NCT07481695

Retrospective Follow-up Study on Lower Eyelid Melanin and Wrinkles After Blepharoplasty for Lower Eyelid Bags

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Eye Hospital

Tianjin, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transconjunctival lower blepharoplasty

Procedure

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 lifting

Procedure

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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