NCT03345381

Brief Summary

People staring at computer screens for long hours, blinking less frequently, or having long-term contact lens wear are prone to dry eye disease (DED). DED is a multifactorial disease accompanied by inflammation of the ocular surface. Further, DED may degrade vision and is associated with depression and have an adverse impact on patient's quality of life. Sudarshan Kriya Yoga (SKY) incorporates standardized collection of breathing techniques followed by Automatic Self Transcending Meditation (ASTM) may help reduce stress, depression, and anxiety, enhance quality of life in patients diagnosed with DED. Thus, the investigators will be studying the effect of SKY plus ASTM on quality of life of DED patients. The investigators plan to conduct a single-center pilot RCT. Patients with DED will be randomized to SKY followed by ASTM plus Usual care (UC) or UC alone to assess changes in health-related quality of life (HRQOL). HRQOL is a vital construct focusing on impact of health on quality of life. Along with HRQOL the investigators will measure changes in extent of depression and anxiety. Additionally, majority of current ophthalmic literature describes changes in clinical variables whilst lacking information on HRQOL. Thus, there is a high necessity to assess if there is an association between HRQOL and routinely measured clinical data. Through this study the investigators shall attempt to correlate HRQOL with clinical data.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

November 14, 2017

Last Update Submit

June 14, 2019

Conditions

DepressionQuality of LifeDry EyeAnxietySleep

Outcome Measures

Primary Outcomes (1)

  • Change in Health Related Quality of Life (HRQoL)

    Health Related Quality of LIfe (HRQoL) is an essential measure of quality of life related to health. HRQoL will be measured using time trade-off (TTO) questionnaire. HRQoL varies between 0 and 1 where the score of 1 represents perfect health and 0 represents death.

    Up to 24 weeks

Secondary Outcomes (7)

  • Visual Function Score

    Up to 24 weeks

  • Depression

    Up to 24 weeks

  • State and Trait Anxiety

    Up to 24 weeks

  • Sleep Quality

    Up to 24 weeks

  • Community Integration

    Up to 24 weeks

  • +2 more secondary outcomes

Study Arms (2)

SKY + ASTM + usual care

EXPERIMENTAL

Sudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) plus usual care

Other: SKY + ASTM + usual care

Usual Care

ACTIVE COMPARATOR

Treatment as usual

Other: Usual care

Interventions

SKY + ASTM + usual careOTHER

Sudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation.

SKY + ASTM + usual care
Usual careOTHER

Treatment as usual

Usual Care

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dry eye disease suspects or have mild to severe dry eye disease
  • at least between 18 to 80 years of age
  • deemed competent such as no language issues or communication barriers, no self-reported or physician diagnosed mental health disorder besides having depressive and anxiety symptoms
  • have sufficient hearing to be able to follow verbal instructions and able to sit without physical discomfort for 30 minutes
  • willing and able to attend 3 initial SKY and 4 initial ASTM training sessions
  • willing to dedicate 20 minutes per day for SKY and 20 minutes twice per day to ASTM practice at their own home.

You may not qualify if:

  • actively suicidal as per self-report (or score on CES-D) or on assessment by the physician
  • they are currently participating in other similar studies
  • currently practicing any type of formal meditation techniques regularly
  • unable or unwilling to answer survey questions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Hospital, Ivey Eye Institute

London, Ontario, N6G0H8, Canada

Location

Related Publications (7)

  • Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.

    PMID: 9402817BACKGROUND

  • Schaumberg DA, Dana R, Buring JE, Sullivan DA. Prevalence of dry eye disease among US men: estimates from the Physicians' Health Studies. Arch Ophthalmol. 2009 Jun;127(6):763-8. doi: 10.1001/archophthalmol.2009.103.

    PMID: 19506195BACKGROUND

  • Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. doi: 10.1016/s0002-9394(03)00218-6.

    PMID: 12888056BACKGROUND

  • Yu J, Asche CV, Fairchild CJ. The economic burden of dry eye disease in the United States: a decision tree analysis. Cornea. 2011 Apr;30(4):379-87. doi: 10.1097/ICO.0b013e3181f7f363.

    PMID: 21045640BACKGROUND

  • Wan KH, Chen LJ, Young AL. Depression and anxiety in dry eye disease: a systematic review and meta-analysis. Eye (Lond). 2016 Dec;30(12):1558-1567. doi: 10.1038/eye.2016.186. Epub 2016 Aug 12.

    PMID: 27518547BACKGROUND

  • Elder C, Nidich S, Moriarty F, Nidich R. Effect of transcendental meditation on employee stress, depression, and burnout: a randomized controlled study. Perm J. 2014 Winter;18(1):19-23. doi: 10.7812/TPP/13-102.

    PMID: 24626068BACKGROUND

  • Burns JL, Lee RM, Brown LJ. The effect of meditation on self-reported measures of stress, anxiety, depression, and perfectionism in a college population. Journal of College Psychotherapy 25(2): 132-144, 2011.

    BACKGROUND

MeSH Terms

Conditions

DepressionDry Eye SyndromesAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorLacrimal Apparatus DiseasesEye DiseasesMental Disorders

Study Officials

  • Monali Malvankar

    University of Western Ontario, Canada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monali Malvankar

CONTACT

5196858500monali.malvankar@sjhc.london.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

July 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

De-identified IPD collected in this study will not be available to other researchers (e.g. outside the primary research group). Because the primary research group has the necessary expertise to conduct analysis and do not need any outside help.

Locations

CA(1)