Skip to content

Post-operative Lower Eyelid Massage for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach

Post-operative Lower Eyelid Massage Versus Standard Care for Prevention of the Lower Eyelid Scare Contracture After Subciliary Approach in Traumatic Facial Fracture Repair, a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06311318
Acronym
RCT
Enrollment
59
Registered
2024-03-15
Start date
2016-11-01
Completion date
2020-09-30
Last updated
2024-03-15

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

Conditions

Infraorbital Rim Fixation, Subciliary Approach Repair, Zygomatic and Lefort II Fractures

Keywords

subciliary incision, subciliary approach, lower eyelid massage, facial fracture, scar contracture, eyelid malposition, ectropion

Brief summary

Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up.

Detailed description

* The massage technique was executed with the patient in a fully open-eyed state, maintaining an upward gaze. The lateral aspect of the distal phalanx of the index finger was employed, exerting pressure on the lower eyelid to bring its margin into contact with the upper eyelid margin for a duration of 10 seconds per repetition. This procedure comprises 10 repetitions per set, administered once hourly, spanning 10 hours daily. The massage instruction was provided either by the authors or plastic surgery residents. * Facial fracture surgeries were conducted by experienced plastic surgeons and/or proficient 4th and 5th year plastic surgery residents at Chiang Mai University Hospital, utilizing the skin-muscle flap subciliary approach. All patients underwent surgery one week after injury to mitigate soft tissue swelling, which had subsided by that time. * Consistent pre-operative, peri-operative, and post-operative care protocols were administered to both patient groups. Stitches at the subciliary incision site were extracted on post-operative day 5. Patients in the massage group were instructed to commence lower eyelid massage on the day when stitches were removed. * The follow-up assessments were occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively. Evaluation criteria include the Grading of Lower Eyelid Scar Contracture (GLESCO). Additionally, grading of lower eyelid malpositioning, comfort scores, rate on a scale of 0-10, adapted from POSAS and Verbal Rating Scale, wound infection, dehiscence, eyelid comfort, and management related to the subciliary incision will be assessed and documented by the plastic surgeon (author) and plastic surgery resident.

Interventions

PROCEDURElower eyelid massage

The massage technique was executed with the patient in a fully open-eyed state, maintaining an upward gaze. The lateral aspect of the distal phalanx of the index finger was employed, exerting pressure on the lower eyelid to bring its margin into contact with the upper eyelid margin for a duration of 10 seconds per repetition. This procedure comprised 10 repetitions per set, administered once hourly, spanning 10 hours daily. The massage instruction was provided either by the authors or plastic surgery residents.

Sponsors

Chiang Mai University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Patients were randomly assigned, using concealed block of four randomization, to either the experimental group receiving lower eyelid massage or the control group receiving standard care. While the authors, acting as massage trainers, were unblinded, an independent plastic surgeon, serving as the assessor, remained blinded to the study interventions.

Intervention model description

A randomized controlled trial enrolled patients with traumatic facial fractures slated for subciliary approach repair. Patients were randomly allocated to the lower eyelid massage (experimental) or standard care (control) groups. The massage group received post-operative instructions. Data on demographics, injury profiles, lower eyelid scar contracture (graded by GLESCO criteria), eyelid malpositioning, comfort scores, and complications were gathered over a 6-month follow-up.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients diagnosed with zygomatic and Lefort II fractures necessitating infraorbital rim fixation following motorcycle accidents, and presenting without external lower eyelid wounds.

Exclusion criteria

* Pre-existing lower eyelid retraction (from previous scar, neurogenic cause, myogenic cause or Graves' disease), incision alteration, communication barriers, inability to perform daily activities or lower eyelid massage (ECOG ≥ 2, PPS Adult Suandok ≤ 60), inability to attend follow-up visits, and patient refusal.

Design outcomes

Primary

MeasureTime frameDescription
Grading of Lower Eyelid Scar Contracture (GLESCO)The follow-up assessments occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively.An anatomical score adapted by the authors, which was not independently validated as it relies on consistent anatomy across patients. Patient in normal neutral gaze, examiner use a finger to push the patient's lower eyelid up to reach upper eyelid, evaluate the lower lid margin compare with cornea Grade 0: Can push lower eyelid up to 100% of cornea Grade 1: Can push lower eyelid up to 75% of cornea Grade 2: Can push lower eyelid up to 50% of cornea Grade 3: Can push lower eyelid up to 25% of cornea Grade 4: Can push lower eyelid less than 25% of cornea
Grading of lower eyelid malpositioningThe follow-up assessments occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively.One of the complications encountered following lower-lid blepharoplasty, ranging in severity from mild lower-lid retraction to frank ectropion with marked lower-lid eversion. Patient in normal neutral gaze, examiner observe position and characteristic of lower eyelid. Grade 0: Normal eye position Grade 1: Lateral rounding of the eye Grade 2: Central sclera show involving limbus Grade 3: Mild eversion of lower lid with tear pooling in inferior cul-de-sac Grade 4: Frank outward eversion of lower lid with exposure of palpebral conjunctiva
Comfort scoresThe follow-up assessments occurred at 1-week, 3-week, 6-week, 3-month, and 6-month intervals post-operatively.Represent subjective clinical evaluations by patients, assessing the overall comfort of the eye, including factors like dryness and tightness of the eyelid, rated on a scale of 0-10, adapted from POSAS and Verbal Rating Scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026