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

NCT06047418 | Completed

• 1 other identifier: 21-03-0300
• Study Type: observational
• Target: 823
• Locations: 1 country
• Sites: 1

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

Conditions

Blepharoptosis; Ptosis, Eyelid; Characteristics Disease; Surgical Incision

Outcome Measures

Primary Outcomes (2)

• 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

  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

  2021-2022

Secondary Outcomes (1)

• surgical evaluations

  2021-2022

Interventions

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• patients diagnosed with blepharoptosis
• complete medical record history

You may not qualify if:

• duplication of previously inputted cases

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Blepharoptosis; Surgical Wound

Interventions

Blepharoplasty

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Dermatologic Surgical Procedures; Plastic Surgery Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Plastic and Reconstructive Surgery Division, Department of Ophthalmology UI - RSCM, Principal Investigator

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: March 15, 2021
• Primary Completion: April 7, 2022
• Study Completion: August 3, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

ID (1)