NCT04636372

Brief Summary

200 participants at Eye Hospital of Wenzhou Medical University during September, 2020 to November, 2020 will be enrolled in this study. The meibomian gland related therapy are pulsed light therapy and meibomian gland hot compress massage.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

November 19, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

September 30, 2020

Last Update Submit

November 12, 2020

Conditions

Xerophthalmia

Outcome Measures

Primary Outcomes (3)

  • The length of meibomian glands after the treatment.

    Length in millimeters.

    up to 2 months

  • The area of meibomian glands after the treatment.

    Area in millimeters\^2.

    up to 2 months

  • The percentage of meibomian glands after the treatment.

    Percentage of meibomian glands in %(area of meibomian glands (mm\^2) and area of palpebral conjunctiva (mm\^2) will be combined to report percentage of meibomian glands in %) are used to assess this outcome measure.

    up to 2 months

Study Arms (3)

Intense pulsed light therapy group

EXPERIMENTAL
Device: Intense pulsed light therapy

Hot compress massage group

EXPERIMENTAL
Other: Hot compress massage

Intense pulsed light therapy and hot compress massage group

EXPERIMENTAL
Device: Intense pulsed light therapyOther: Hot compress massage

Interventions

Intense pulsed light therapyDEVICE

Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.

Intense pulsed light therapy and hot compress massage groupIntense pulsed light therapy group
Hot compress massageOTHER

Patients with xerophthalmia were treated with hot compress massage of meibomian gland.

Hot compress massage groupIntense pulsed light therapy and hot compress massage group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Previously untreated patients with xerophthalmia

You may not qualify if:

  • No history of ocular surgery and trauma
  • Any eye diseases except xerophthalmia
  • No treated for xerophthalmia before
  • Successful completion of follow-ups

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Xerophthalmia

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesDry Eye SyndromesLacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

September 30, 2020

First Posted

November 19, 2020

Study Start

September 1, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

November 19, 2020

Record last verified: 2020-09