Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06047418 |
| Other study ID # |
21-03-0300 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2021 |
| Est. completion date |
August 3, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Indonesia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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.
