The Indonesian Research on Survey and Treatment for Dry Eye Disease (ThIRST DED): Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- OSDI questionnaire score
研究概览
简要总结
The goal of this clinical trial is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% to prevent dry eye disease in patient who will undergo cataract surgery. The main questions it aims to answer are:
- The percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery.
- The differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively.
- The tear osmolarity and matix metalloproteinase-9 (MMP-9) after the treatment.
- The difference in visual quality improvement assessed from higher order aberrations (HOA) and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%.
Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery, and will be:
- Interviewed regarding their identity, history of illness, and symptoms of dry eye disease.
- Examined by researchers: eye condition, contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time (TBUT) , fluorescein break up pattern (FBUP).
This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
详细描述
The general objective of this study is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% for patient who will undergo cataract surgery. The objective is being measure by the reducing symptoms and milder signs of dry eye disease and improving vision quality in post-cataract surgery patients.
- Evaluate the percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery with diquafosol sodium 3% compared to sodium hyaluronate 0.1% in patients who want to undergo cataract surgery.
- Evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively by examining the value of break up time, corneal sensibility, keratograph and FBUP
- Evaluate tear osmolarity and MMP-9 after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%
- Evaluate the difference in visual quality improvement assessed from HOA and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%
Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery.
The steps of the research examination are as follows:
A) History
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract patients who will undergo phacoemulsification procedures and intraocular lens (IOL) implants
- •Patients with dry eye disease
- •Patients are willing to participate in the study and fill out informed consent
排除标准
- •Subjects with lacrimal gland or eyelid disorders (ptosis, blepharospasm, lagophthalmos, entropion, ectropion, and blepharitis)
- •There are complications after cataract surgery
- •Patients with a history of using topical medications / eye drops that are used routinely
- •History of eye surgery in the last 6 months
- •Serious ocular surface disorders (Sjögren syndrome, pemphigoid, chemical trauma)
- •Using regular medication that trigger dry eye conditions (eg antihistamines, antidepressants, decongestants, anticholinergics) / allergy to diquafosol drugs
研究组 & 干预措施
Diquafosol sodium 3% group
Diquafosol sodium 3% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
干预措施: Diquafosol sodium 3% (Drug)
Sodium hyaluronate 0.1% group
Sodium hyaluronate 0.1% 4 times a day for 4 weeks before cataract surgery and 21 days after surgery
干预措施: Sodium hyaluronate 0.1% (Drug)
结局指标
主要结局
OSDI questionnaire score
时间窗: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively with OSDI questionnaire. The OSDI score results will be assessed. Lower scores mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Tear break up time value
时间窗: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of tear break up time. Higher value in tear break up time mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Fluorescein break up pattern
时间窗: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the fluorescein break up pattern. The fluorescein break up pattern results will be categorized and analyzed descriptively. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Corneal sensibility using Cochet Bonnet esthesiometer
时间窗: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of corneal sensibility using cochet bonnet esthesiometer. Any changes to the value will be assessed. Higher value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Higher Order Aberrations (HOA) value using oculyzer device
时间窗: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of Higher Order Aberrations (HOA) using oculyzer device to assess the corneal aberrations. Lower value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Tear osmolarity using TearLab device
时间窗: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively objectively by examining the value of tear osmolarity using TearLab device. Lower value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Contrast sensitivity value using Pelli-Robson Contrast Sensitivity Chart
时间窗: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of contrast sensitivity using Pelli-Robson Contrast Sensitivity Chart. Higher value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Matrix metalloproteinase-9 value using Human MMP-9 ELISA Kit
时间窗: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients objectively by examining the value of matrix metalloproteinase-9 using Human MMP-9 ELISA Kit. Lower value mean a better outcome. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
Keratograph device to assess tear meniscus height, noninvasive keratograph tear break up time (NIKBUT), and redness
时间窗: 4 months
This study will evaluate differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs and symptoms in patients subjectively objectively by examining the patients using keratograph device to assess the tear meniscus height, noninvasive keratograph tear break up time (NIKBUT), and redness. The results will be categorized and analyzed descriptively. This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.
次要结局
未报告次要终点
研究者
Prof. Dr. dr. Ratna Sitompul, Sp.M(K)
Prof. Dr. dr. Ratna Sitompul, Sp.M(K)
Indonesia University