Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:14 AM
Study NCT ID:
NCT07481695
Status:
COMPLETED
Last Update Posted:
2026-03-19
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Follow-up Study on Lower Eyelid Melanin and Wrinkles After Blepharoplasty for Lower Eyelid Bags
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-15', 'studyFirstSubmitDate': '2026-03-15', 'studyFirstSubmitQcDate': '2026-03-15', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Barton's grading scale", 'timeFrame': 'Before the operation, and six months after the operation', 'description': '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.'}, {'measure': 'Global Aesthetic Improvement Scale', 'timeFrame': 'Before the operation, and six months after the operation', 'description': '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.'}, {'measure': 'Periorbital hyperpigmentation assessment', 'timeFrame': 'Before the operation and six months after the operation', 'description': '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.'}, {'measure': 'Wrinkles in the lower eyelid', 'timeFrame': 'Before the operation and six months after the operation.', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wrinkle Appearance', 'Melanin Hyperpigmentation']}, 'descriptionModule': {'briefSummary': '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.\n\nThe study addresses the following research questions:\n\nDoes 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07481695', 'briefTitle': 'Retrospective Follow-up Study on Lower Eyelid Melanin and Wrinkles After Blepharoplasty for Lower Eyelid Bags', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College'}, 'officialTitle': 'Retrospective Follow-up Study on Lower Eyelid Melanin and Wrinkles After Blepharoplasty for Lower Eyelid Bags', 'orgStudyIdInfo': {'id': '2026（084）'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transconjunctival lower blepharoplasty', 'description': 'conventional transconjunctival lower blepharoplasty, this conventional approach combined of transconjunctival intraorbital fat excision and fat transplantation.', 'interventionNames': ['Procedure: transconjunctival lower blepharoplasty']}, {'label': 'Transconjunctival lower blepharoplasty combined with POD lifting', 'description': 'conventional transconjunctival lower blepharoplasty combined POD lifting in order to alleviate postoperative skin laxity.', 'interventionNames': ['Procedure: transconjunctival lower blepharoplasty', 'Procedure: POD lifting']}], 'interventions': [{'name': 'transconjunctival lower blepharoplasty', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Transconjunctival lower blepharoplasty', 'Transconjunctival lower blepharoplasty combined with POD lifting']}, {'name': 'POD lifting', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Transconjunctival lower blepharoplasty combined with POD lifting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Xiaolei Jin', 'investigatorAffiliation': 'The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College'}}}}