Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patient

Dry Eye Syndromes Clinical Trial

Official title:

Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patients With Meibomian Gland Dysfunction Prior to Cataract Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04391907
• Other study ID #: 2019-07-016
• Status: Withdrawn
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: March 2, 2021

Study information

• Verified date: May 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.

Description:

IPL procedure is a device used for symptom relief and treatment of dry eye syndrome caused by meibomian gland dysfunction in adults, and its safety and long-term effects have been confirmed. The purpose of this study is to determine whether this procedure before cataract surgery is effective in improving the symptoms of dry eye syndrome after cataract surgery.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. A patient at the age of 21 cataract surgery

2. A patient has the visual potential of 20/25 or better in each eye after cataract removal

3. Dry eye patient by meibomian gland dysfunction

4. Written informed consent to surgery and participation in the study

Exclusion Criteria:

1. Eye damage, active eye infection

2. Uncontrolled health problem

3. Wear contact lens within one month

4. Allergic reactions of fluorescein sodium or ophtalmic anesthetic

5. Eye surgery and trauma in the last six months

6. Eye disease, structural abnormality

7. If there is a cause of vision loss other than cataracts

8. Under 20/25 expect vision

9. Under the age of 20 years of age

10. Pregnant woman and lactating woman

11. Medical conditions in which IPL is contraindicated

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Procedure:
• IPL
Intense pulse light (IPL) laser is used for the treatment of dry eye originated from meibomian gland dysfunction. IPL laser will be performed to patients who are planned to cataract surgery to improve dry eye.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TBUT	tear break-up time	3 months
Primary	meibomian gland function score	By expression of eyelid, scoring of expressibility and quality of meibum will be tested. Form of secretion predominantly secreted by the eight meibomian glands in the center of the lid was evaluated as follows. grade 0, clear meibum is easily expressed; grade 1, cloudy meibum is expressed with mild pressure; grade 2, cloudy meibum is expressed with more than moderate pressure; and grade 3, meibum cannot be expressed even with the hard pressure. Higher score means a worst outcome.	3 months
Secondary	OSDI	questionnaire to evaluate dry eye symptoms. OSDI grading (0 ~ 100) was as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). Higher score means a worse outcome.	3 months
Secondary	Corneal staining score	Punctate epithelial erosion of cornea will be evaluated with standard classification system(NEI score, National Eye Institute score). It divides the cornea into five sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the PEE, for a maximum of 15 points. Higher score means a worse outcome.	3 months