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Evaluation of periocular swelling after blepharoplasty using 3D image analysis - no postoperative cooling in comparison to Hilotherapy

Evaluation of periocular swelling after blepharoplasty using 3D image analysis - no postoperative cooling in comparison to Hilotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015261
Enrollment
40
Registered
2018-08-31
Start date
2019-11-11
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatochalasis of eyelid

Interventions

Group 1: 20 right eyes in 20 patients (1 eye per patient) were treated with Hilotherapy 60 min after blepharoplasty. Group 2: 20 left eyes in other 20 patients (1 eye per patient) were treated with Hi

Sponsors

Universität zu Köln Klinik und Poliklinik für Augenheilkunde
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Indication for blepharoplasty in patients with upper lid blepharochalasis or dermatochalasis.

Exclusion criteria

Exclusion criteria: Missing operability, foreseeable missing opportunity for follow-up examination, non-consenting patient, pregnancy, severe heart and circulation diseases, malignant diseases as well as blood coagulation disorders and allergic reactions to pharmaceuticals. Congenital eye deformities or congenital syndromes that surround the eye area, inflammatory eye diseases, sicca syndrome (dry eye disease), already received operations of eyelids, ocular traumas and other eye diseases influencing eyelid function.

Design outcomes

Primary

MeasureTime frame
Swelling: 3D optical scans will be recorded at 5 points in time: T0 (preoperative scan), T1 (immediately after postoperative cooling treatment), T2 (the 1st day after surgery), T3 (the 2nd weeks after surgery), T4 (the 12th weeks after surgery). Pain: The pain scores for each patient will be recorded at 5 points- T0 (preoperative), T1 (immediately after postoperative cooling treatment), T2 (the 1st day after surgery), T3 (the 2nd weeks after surgery), T4 (the 12th weeks after surgery). Pain analysis will be performed using an 11-point visual analogue scale (VAS 0 = no pain, VAS 10 = maximum intensity of pain). Edema: Postoperative palpebral edema will be evaluated subjectively in 3D photos using a four-point score: 0 denotes no palpebral edema; 1 mild palpebral edema, palpebral aperture was not decreased considerably; 2 moderate palpebral edema, palpebral aperture narrowed significantly; 3 severe palpebral edema, palpebral aperture almost disappeared. It will be recorded at 4 points: T1 (immediately after postoperative cooling treatment), T2 (the 1st day after surgery), T3 (the 2nd weeks after surgery), T4 (the 12th weeks after surgery) Patient Comfort: Each patient will be asked to complete a questionnaire at 5 points- T0 (preoperative), T1 (immediately after postoperative cooling treatment), T2 (the 1st day after surgery), T3 (the 2nd weeks after surgery), T4 (the 12th weeks after surgery). They will rate their comfort with the applied postoperative cooling therapy on a 11-point scale. The grading scale ranges from 0 to 10, where 0 denoted “very comfortable” and 10 for “very uncomfortable”.

Secondary

MeasureTime frame
Palpebral fissure length, Palpebral fissure height, eye fissure index, upper lid sulcus height, upper lid height, sulcus index, upper eyelid margin arc length, eyebrow height, canthal index , medial canthal angle, lateral canthal angle, canthal tilt.

Countries

Germany

Contacts

Public ContactLudwig Heindl

Universität zu Köln Klinik und Poliklinik für Augenheilkunde

ludwig.heindl@uk-koeln.de+49 221 478-5862

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026