Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06047418
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2023-09-14
Brief Title:
Blepharoptosis in Indonesia A 5-Year Multicenter Study on Characteristics and Surgical Evaluation
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Blepharoptosis in Indonesia A 5-Year Retrospective Cross-Sectional Multicenter Study on Characteristics and Surgical Evaluation
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
- 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 80 prevalence of childhood blepharoptosis8 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 used7 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 eyes9 Levator muscle function LF assessment classified into excellent 13 mm good 8 to 11 mm fair 50 to 7 mm and poor 4 mm Severity was gauged as mild MRD 2 mm moderate MRD 3-4mm or severe MRD 4mm10 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 Fishers 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 p005 indicates that our models predictions match the observed outcomes suggesting that the model fits the data well
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 80 prevalence of childhood blepharoptosis8 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 used7 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 eyes9 Levator muscle function LF assessment classified into excellent 13 mm good 8 to 11 mm fair 50 to 7 mm and poor 4 mm Severity was gauged as mild MRD 2 mm moderate MRD 3-4mm or severe MRD 4mm10 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 Fishers 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 p005 indicates that our models predictions match the observed outcomes suggesting that the model fits the data well
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None