Managing Dry Eye in Patients Using Glaucoma Drops

NCT ID: NCT06158984

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-03

Study Completion Date

2023-12-02

Brief Summary

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A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.

Detailed Description

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To compare the safety and efficacy of IPL therapy on drug-induced dry eye caused by long-term use of anti glaucoma drugs;

Conditions

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Dry Eye

Keywords

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Glaucoma IPL Diquafosol Drug-induced Dry Eye

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective, comparative pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the two groups.

Study Groups

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IPL group

IPL group will use 2 sessions of IPL therapy, 15 days apart for the management of drug-induced dry eye in glaucoma patients.

Group Type EXPERIMENTAL

IPL

Intervention Type DEVICE

Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients.

Control group

The control group received no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IPL

Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients.

Intervention Type DEVICE

Other Intervention Names

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Intense pulsed light

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* Able and willing to comply with the treatment/follow-up schedule
* Bilateral signs and symptoms of dry eye disease

Exclusion Criteria

* Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease
* Patients using topical medication(s) for the treatment of ocular disorders such as allergic conjunctivitis were excluded from the study.
* Previous ocular surgery or trauma
* 1-month history of blepharal and periorbital skin disease or allergies
* Severe dry eyes with corneal epithelial defect
* Limbic keratitis
* Pterygium
* Corneal neovascularization
* Breastfeeding
* Rheumatic immune systemic diseases
* Herpes zoster infection
* Pregnant women
* Allergic to fluorescein
* Contact lens wearers
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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He Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel Eric Pazo

Role: STUDY_CHAIR

He Eye Hospital, Shenyang, China

Locations

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He Eye Hospital

Shenyang, Liaoning, China

Site Status

Countries

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China

References

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Zhang H, Qi Y, Chen J, Qin G, Xu L, He W, Yu S, Che H, Pazo EE. Management of Glaucoma-Related Dry Eye Disease with Intense Pulsed Light: A Randomized Control Study. Clin Ophthalmol. 2024 Jul 15;18:2061-2072. doi: 10.2147/OPTH.S471426. eCollection 2024.

Reference Type DERIVED
PMID: 39055379 (View on PubMed)

Other Identifiers

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GLADQSLIP2023

Identifier Type: -

Identifier Source: org_study_id