Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery in a Prospective Randomized Controlled Inter-eye Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Inter-eye difference in Schirmer Test 1 at month 1
研究概览
简要总结
Dry eye disease can occur or worsen after cataract surgery and may cause ocular discomfort and reduced visual quality. Standard treatment commonly includes artificial tear eye drops, which provide temporary lubrication. Temporary occlusion of the tear drainage system may offer an alternative approach by increasing tear retention and improving tear film stability.
This prospective, randomized, double-blind, inter-eye study will evaluate the use of LACRIFILL® Canalicular Gel, a crosslinked hyaluronic acid gel placed in the tear drainage system, in patients who have undergone bilateral cataract surgery. Treatment allocation will be randomized at the eye level within each participant. One eye will be assigned to treatment with LACRIFILL®, while the fellow eye will serve as the control and receive standard care with artificial tear eye drops.
The study will compare the development and severity of dry eye disease between the randomized treatment and control eyes. The main outcome will be tear production measured by the Schirmer Test 1 one month after treatment. Additional assessments will include tear film stability, ocular surface findings, anterior segment imaging, visual quality, dry eye symptoms, use of artificial tears, and treatment-related safety outcomes during a three-month follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncomplicated bilateral cataract surgery for age-related cataract within the last 2-7 days
- •Implantation of the same type of lens in both eyes (diopters may differ).
- •Age 45-99 years
- •Willingness to complete the study
- •Signed informed consent form
排除标准
- •Bilateral cataract due to a different cause
- •Retinal findings affecting quality of life or visual acuity in any eye
- •History of uncontrolled glaucoma in any eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
- •Active or suspected ocular or periocular infection in the study eye.
- •Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye.
研究组 & 干预措施
LACRIFILL® Canalicular Gel Lacrimal Occlusion
Within each participant, one eye will be randomly assigned to receive a single intracanalicular administration of LACRIFILL® Canalicular Gel into the lower canaliculus. The intervention is intended to provide temporary occlusion of the lacrimal drainage system and thereby reduce tear drainage and increase tear retention. The fellow eye will serve as the control eye.
干预措施: LACRIFILL® Canalicular Gel administration (Device)
Lacrimal Irrigation
The fellow eye of each participant will undergo lacrimal irrigation as a sham procedure. No LACRIFILL® Canalicular Gel will be administered to the control eye. The control eye will otherwise receive standard postoperative care, including artificial tear supplementation, according to standard clinical practice.
干预措施: Sham lacrimal canalicular procedure (Procedure)
结局指标
主要结局
Inter-eye difference in Schirmer Test 1 at month 1
时间窗: 1 months
Difference in Schirmer Test I tear production between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 month after cataract surgery. Schirmer Test I measures tear production as the length of wetting of a standardized filter paper strip over 5 minutes, expressed in millimeters (mm). Values for each eye range from 0 to 35 mm, with higher values indicating greater tear production. The inter-eye difference is calculated as the Schirmer Test I value in the Lacrifill-treated eye minus the value in the standard-of-care eye, resulting in a possible range of -35 to +35 mm. Positive values indicate greater tear production in the Lacrifill-treated eye.
次要结局
- Inter-eye difference in Schirmers Test 1 at month 3(3 Months)
- Inter-eye difference in Oxford grading at month 1 and months 3(1 month, 3 months)
- Inter-eye difference in tear break up time (TBUT) at month 1 and 3(1 month; 3 months)
- Non-invasive tear break-up time measured with the MS-39 at Months 1 and 3(1 month; 3 months)
- Halo/glare size measured with the Real Artificial Lens Vision (RALV) system(1 month and 3 months)
- Outcomes of questionnaires(1 month; 3 months)
- Number of applied artifical tear drops(3 months)
- Incidence of adverse events and device- or procedure-related adverse events(3 months)
- Inter-eye difference in visual quality assessment(1 month; 3 months)
研究者
Gregor Reiter
Ap.Prof. PD. DDr. BA, MSc,
Medical University of Vienna