Blepharoptosis in Indonesia: A 5-Year Multicenter Study on Characteristics and Surgical Evaluation

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT06047418
Collaborator
(none)
823
1
28.6
28.8

Study Details

Study Description

Brief Summary

The goal of this observational study is to learn about blepharoptosis cases in national referral hospitals in Indonesia. The main questions it aims to answer are:

  • How is the clinical characteristics, types, and surgical evaluations of blepharoptosis in this particular setting

Participant who include in this study is a patient diagnosed with blepharoptosis cases and complete medical history from January 2016 to December 2020 across 10 tertiary hospitals in Indonesia from 5 provinces

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blepharoplasty

Detailed Description

The research obtained data from the medical records of 823 patients across 10 tertiary hospitals in Indonesia from 5 provinces including Cipto Mangunkusumo Hospital (Jakarta), JEC Eye Hospitals & Clinics (Jakarta), Mohammad Hoesin Hospital, Saiful Anwar Hospital, Cicendo Hospital, Sanglah Hospital, M Djamil Hospital, Wahidin Sudirohusodo Hospital, Sardjito Hospital, Kariadi Hospital, and Soetomo Hospital. Inclusion criteria entailed fully completed patient data, while exclusion criteria encompassed duplicated patient data across different years.

Patient demographic data, encompassing gender, age, and ethnicity, were extracted from the collected data. Age was divided into two groups: children (0-18 years) and adults (19-40 years, and ≥40 years). This investigation incorporated pediatric participants to assess the occurrence of blepharoptosis in children, prompted by a study revealing an 8.0% prevalence of childhood blepharoptosis.8 In age-specific relative incidence of blepharoptosis, aponeurotic and myogenic ptosis was the majority in patients younger than 40 years, emphasizing the significant association between older age and blepharoptosis prevalence, hence a cut-off of 40 years was used.7 Patient blepharoptosis classifications were established according to etiology, dividing cases into congenital and acquired categories. Acquired instances encompassed diverse etiologies (myogenic, aponeurotic, mechanical, neurogenic, traumatic, and pseudoptotic ptosis). Physical examinations discerned specific blepharoptosis traits, categorizing types as unilateral (palpebral fissure asymmetry >1 mm) and bilateral (marginal reflex distance (MRD) >2mm in both eyes).9 Levator muscle function (LF) assessment classified into excellent (≥13 mm), good (8 to 11 mm), fair (5.0 to 7 mm), and poor (≤4 mm). Severity was gauged as mild (MRD ≤2 mm), moderate (MRD 3-4mm), or severe (MRD ≥ 4mm).10 For surgical outcome evaluation, analysis depended on surgical method, success rate, and complications, divided into recurrence requiring re-operation, undercorrection, overcorrection, lagophthalmos, and asymmetry. Utilizing SPSS Statistics 25, the study employed Chi-square or Fisher's exact test and logistic regression to explore variable relationships. Initially, odds ratios were determined with bivariate analysis to examine the raw relationship between each independent variable and the outcome, without any control for other variables. Furthermore, we also computed odds ratios with multivariate analysis, which consider the simultaneous effect of multiple variables on the outcome. For this purpose, we used the stepwise method. The adequacy of our logistic regression model was assessed using the Hosmer and Lemeshow Test. A non-significant result from the Hosmer and Lemeshow Test (p>0.05) indicates that our model's predictions match the observed outcomes, suggesting that the model fits the data well.

Study Design

Study Type:
Observational
Actual Enrollment :
823 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Blepharoptosis in Indonesia: A 5-Year Retrospective Cross-Sectional Multicenter Study on Characteristics and Surgical Evaluation
Actual Study Start Date :
Mar 15, 2021
Actual Primary Completion Date :
Apr 7, 2022
Actual Study Completion Date :
Aug 3, 2023

Outcome Measures

Primary Outcome Measures

  1. Demographic and Clinical Characteristic [2021-2022]

    demographics were categorised into sex, age and race while clinical characteristic were including type of ptosis, laterality, mechanism, severity, elevator function. we use percentage to calculate the proportion of the patients

  2. Surgical technique [2021-2022]

    we collect the data history of patient's eyes who were undergoing the surgery. we use percentage to calculate the proportion of each surgical technique used as frontal suspension, levator resection, elevator advancement, fasanella servant, mullerectomy and tumor excision

Secondary Outcome Measures

  1. surgical evaluations [2021-2022]

    surgical evaluations were observed and calculated from the current complications appeared in percentage

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients diagnosed with blepharoptosis

  • complete medical record history

Exclusion Criteria:
  • duplication of previously inputted cases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cipto Mangunkusumo Hospital Jakarta Pusat DKI Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yunia Irawati, Director, Head of Plastic and Reconstructive Surgery Division, Department of Ophthalmology UI - RSCM, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT06047418
Other Study ID Numbers:
  • 21-03-0300
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023