BlepharoptosisNCT06047418
Blepharoptosis in Indonesia: A 5-Year Multicenter Study on Characteristics and Surgical Evaluation
An observational study of Blepharoptosis and Ptosis, Eyelid, run by Universitas Indonesia at 1 site in Indonesia.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Blepharoptosis, Ptosis, Eyelid, Characteristics Disease
- What is being tested?
- Blepharoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 823 participants
- Where
- 1 siteIndonesia
- Study dates
- 15 Mar 2021to 3 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: registered blepharoptosis cases from January 2016 to December 2020 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 Sudirohusudo Hospital, Sardjito Hospital, Kariadi Hospital, and Soetomo Hospital
Who may be able to join
- patients diagnosed with blepharoptosis
- complete medical record history
Who cannot join
- duplication of previously inputted cases
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Blepharoptosis in Indonesia: A 5-Year Retrospective Cross-Sectional 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
Read the 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.
- Being tested
- Blepharoplasty
- Medical subject headings
- Blepharoptosis, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlepharoplastyProcedure or surgery
This is an cross-sectional, retrospective observational study, to evaluate the clinical characteristics and surgical outcome of blepharoptosis patients who undergone the surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic and Clinical Characteristic
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
Measured: 2021-2022
Surgical technique
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
Measured: 2021-2022
Secondary outcomes (1)
surgical evaluations
surgical evaluations were observed and calculated from the current complications appeared in percentage
Measured: 2021-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Mar 2021
- Primary completion7 Apr 2022
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 823 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunia Irawati, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047418
- Sponsor's protocol ID
- 21-03-0300
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It depends on what is the aim of the research, and we should collaborate to do the research
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blepharoptosis in Indonesia: A 5-Year Retrospective Cross-Sectional Multicenter Study on Characteristics and Surgical Evaluation
- ClinicalTrials.gov ID
- NCT06047418
- Acronym / sponsor ID
- 21-03-0300
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- registered blepharoptosis cases from January 2016 to December 2020 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 Sudirohusudo Hospital, Sardjito Hospital, Kariadi Hospital, and Soetomo Hospital
Key inclusion criteria (2 listed)
- patients diagnosed with blepharoptosis
- complete medical record history
Key exclusion criteria (1 listed)
- duplication of previously inputted cases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlepharoplastyThis is an cross-sectional, retrospective observational study, to evaluate the clinical characteristics and surgical outcome of blepharoptosis patients who undergone the surgery | Procedure or surgery | – |
Primary outcome
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
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
1 secondary outcome
surgical evaluations
Time frame: 2021-2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Undecided. It depends on what is the aim of the research, and we should collaborate to do the research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharoptosis and Ptosis, Eyelid, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic and Clinical Characteristic (time frame: 2021-2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.