UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062775 |
|---|---|
| Receipt number | R000071867 |
| Scientific Title | Postoperative Eyelid Cleansing with Wipes for the Prevention of Iatrogenic Meibomian Gland Dysfunction and Dry Eye After Cataract Surgery |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/09/01 22:16:51 |
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Basic information
Public title
Postoperative Eyelid Cleansing with Wipes for the Prevention of Iatrogenic Meibomian Gland Dysfunction and Dry Eye After Cataract Surgery
Acronym
Postoperative Lid Hygiene after Cataract Surgery
Scientific Title
Postoperative Eyelid Cleansing with Wipes for the Prevention of Iatrogenic Meibomian Gland Dysfunction and Dry Eye After Cataract Surgery
Scientific Title:Acronym
CLEANS Study
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity: Uncorrected visual acuity (UCVA), Best-corrected visual acuity (BCVA)
Intraocular pressure (IOP)
Subjective symptoms
SPEED (Standard Patient Evaluation of Eye Dryness) score: 0-28
The frequency and severity of dry eye symptoms will be assessed and summed to obtain the total SPEED score.
Visual Analog Scale (VAS): 0 (no symptoms) to 100 (worst possible symptoms)
Eight symptoms will be assessed independently: dryness, eye fatigue, ocular discomfort, blurred vision, foreign body sensation, ocular pain, heaviness of the eyes, and difficulty opening the eyes.
Slit-lamp examination of the upper and lower eyelids
Discharge, secretions, and debris on the eyelid margins and lash roots: graded on a 0, 0.5, 1, 2, and 3 scale.
Eyelid margin findings:
Plugging: number of obstructed meibomian gland orifices among 10 orifices in the central portion of the eyelid.
Eyelid margin vascularity: graded from 0 to 3 within the central region containing 10 meibomian gland orifices.
Fluorescein tear film break-up time (FBUT): measured three times, with the mean value used for analysis.
Corneal and conjunctival epithelial damage score: corneal and conjunctival epithelial damage will be assessed using fluorescein staining on a 0-9 scale.
Presence or absence of corneal erosion
Other anterior segment findings
Meibum grade: the upper eyelid will be gently compressed for 5 seconds, and the ease of meibum expression and meibum quality will be assessed on a 0-3 scale.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
3370042
Address
626-11, Minaminakano, Minuma-ku, Saitama City, Saitama, Japan
TEL
0486865588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
3370042
Address
626-11, Minaminakano, Minuma-ku, Saitama City, Saitama, Japan
TEL
0486865588
Homepage URL
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamauchi Clinic
Address
1-15-19, Jiyugaoka, Meguroku, Tokyo, Japan
Tel
0337237717
fujii.tetsuya@neues.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 01 | Day |
Last modified on
| 2026 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071867
