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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06047418
Enrollment
823
Registered
2023-09-21
Start date
2021-03-15
Completion date
2023-08-03
Last updated
2023-09-21

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

Conditions

Blepharoptosis, Characteristics Disease, Ptosis, Eyelid, Surgical Incision

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

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.

Interventions

This is an cross-sectional, retrospective observational study, to evaluate the clinical characteristics and surgical outcome of blepharoptosis patients who undergone the surgery

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patients diagnosed with blepharoptosis * complete medical record history

Exclusion criteria

* duplication of previously inputted cases

Design outcomes

Primary

MeasureTime frameDescription
Demographic and Clinical Characteristic2021-2022demographics 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
Surgical technique2021-2022we 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

MeasureTime frameDescription
surgical evaluations2021-2022surgical evaluations were observed and calculated from the current complications appeared in percentage

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026