Tokyo, Sept. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062775) titled 'Postoperative Eyelid Cleansing with Wipes for the Prevention of Iatrogenic Meibomian Gland Dysfunction and Dry Eye After Cataract Surgery' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - Itoh Clinic
Condition:
Condition - Cataract
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Participants will be allocated to one of two groups using the envelope method. In the eyelid cleansing group, the eyelid margins and lash roots will be cleansed with periocular cleansing wipes after postoperative eye-drop instillation. In the control group, only excess eye drops around the eyes will be wiped away using sterile disposable gauze. The safety and efficacy of postoperative eyelid cleansing will be evaluated by comparing the two groups.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Eyelid cleansing group:
Participants in the eyelid cleansing group will use Eye Cleansing Wipes (Moisturizing Type) manufactured by Dr. Fischer. After instillation of postoperative eye drops, the upper and lower eyelid margins and lash roots will be gently wiped three times from the inner canthus toward the outer canthus. Eyelid cleansing will be performed four times daily from 30 minutes after surgery through postoperative week 1, and twice daily thereafter through postoperative week 4.
For both groups, at the time of the first postoperative eye drop instillation, approximately 30 minutes after completion of cataract surgery, a nurse will instruct each participant in the assigned procedure using the corresponding written instruction sheet.
Interventions/Control_2 - Control group:
Participants in the control group will use Sterile Disposable Gauze III manufactured by Osaki Medical Co., Ltd. After instillation of postoperative eye drops, only excess eye drops around the eye will be gently wiped away. This procedure will be performed four times daily from 30 minutes after surgery through postoperative week 1, and twice daily thereafter through postoperative week 4.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Participants who provide written informed consent to participate in this study and meet all of the following criteria will be eligible:
Age: 18 years or older at the time of informed consent
Sex: No restriction
Patients undergoing cataract surgery for the first time
Patients who are able to personally complete and sign the informed consent form
Key exclusion criteria - Exclusion criteria
Patients with acute ocular or eyelid disease
Patients with clinically evident eyelid or ocular surface disease, including congenital eyelid abnormalities, entropion, ectropion, pterygium, or Sjogren syndrome
Patients with thyroid eye disease or neurological disorders, including oculomotor nerve palsy, myasthenia gravis, or Horner syndrome
Patients using topical anti-glaucoma medications
Patients with a history of eyelid surgery, including ptosis surgery or double-eyelid surgery, or a history of facial bone fracture
Patients with a history of ocular surgery, intense pulsed light (IPL) treatment, LASIK, botulinum toxin injection, or punctal plug insertion
Patients with ocular allergic symptoms at the time of examination
Patients considered unsuitable for participation by the principal investigator or a study investigator
Target Size - 100
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 01 Month 17 Day
Date of IRB - 2025 Year 01 Month 18 Day
Anticipated trial start date - 2026 Year 09 Month 02 Day
Last follow-up date - 2026 Year 10 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071867
Disclaimer: Curated by HT Syndication.
