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Completed

NCT Number: NCT06047418

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

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with blepharoptosis
  • complete medical record history

Exclusion criteria

  • duplication of previously inputted cases

Treatment and study plan

Blepharoplasty

Procedure

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

Primary outcomes

  1. Demographic and Clinical Characteristic

    Time frame: 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

    Time frame: 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 outcomes

  1. surgical evaluations

    Time frame: 2021-2022

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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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