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Surgical Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis

NCT04720586 — Not applicable, Unknown, 40 participants, Benha University

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Lower Eyelid Retractors Plication , Transcutaneous Blepharoplasty and Wedge Resection for Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis

RegistryNCT04720586
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment40 (Estimated)
SponsorBenha University (Other)
ConditionsEyelid Diseases
Interventionslower eyelid blepharoplasty , retractor plication and wedge resection, lower eyelid blepharoplasty and retractor plication (Procedure)
Datesstart 2020-08-01, primary completion 2022-08-01 (estimated), completion 2022-08-31 (estimated), first posted 2021-01-22, last updated 2021-01-28
Locations1 site in United Arab Emirates

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-Summary

lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results.

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+Detailed description

traditional lower eyelid transcutaneous blepharoplasty ; subciliary incision followed by proper dissection then lower eyelid retractors plication after orbital fat removal . pentagon wedge resection of lateral lower eyelid is done

+Arms and interventions

ArmTypeInterventionsDescription
triple procedureExperimentalProcedure: lower eyelid blepharoplasty , retractor plication and wedge resection; Procedure: lower eyelid blepharoplasty and retractor plicationlower eyelid retractors plication , transcutaneous blepharoplasty and wedge resection
combined procedureActive comparatorProcedure: lower eyelid blepharoplasty , retractor plication and wedge resection; Procedure: lower eyelid blepharoplasty and retractor plicationlower eyelid retractors plication and transcutaneous blepharoplasty
  • lower eyelid blepharoplasty , retractor plication and wedge resection (Procedure): combined lower eyelid blepharoplasty , retractor plication and wedge resection
  • lower eyelid blepharoplasty and retractor plication (Procedure): combined lower eyelid blepharoplasty and retractor plication procedures

+Outcome measures

Primary outcomes

  • Global Aesthetic Improvement Scale [12 months]: calculate scale score (1-5); score 1 is exceptional improvement , score 5 is worsened patient

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Lower eyelid involutional entropion
2. dermatochalasis

Exclusion Criteria:

1. Other eyelid disease,
2. Other causes of entropion
3. Previous eyelid surgery

+Locations (1)

FacilityCityCountryStatus
INMCAbu DhabiUnited Arab EmiratesRecruiting

+Investigators

My Notes