NCT06913452

Brief Summary

To evaluate the effect of obesity on tear film and ocular health in diabetic patients. Research Design An observational cross-sectional study will be conducted.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Tear Film Deficiency

Outcome Measures

Primary Outcomes (1)

  • The Oswestry Disability Index (ODI)

    The Oswestry Disability Index (ODI) is a questionnaire used to assess functional disability in individuals with low back pain, with scores ranging from 0% (no disability) to 100% (maximum disability), and interpreted as follows: 0-20% minimal disability, 21-40% moderate, 41-60% severe, 61-80% crippling, and 81-100% bed-bound or exaggerated symptom

    12 Months

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diabetic participants aged 18-70 with varying BMI categories will be assessed for tear production and film stability using Schirmer's Test and Tear Break-Up Time (TBUT). Demographics, medical history, and ocular health will also be recorded in a controlled clinic environment.

You may qualify if:

  • Adults (18+ years)
  • diagnosed with type 1 or type 2 diabetes
  • categorized as obese or non-obese (BMI \>30 or \<30)
  • stable glycemic control, and willing to provide consent.

You may not qualify if:

  • Non-diabetic individuals
  • pregnant/lactating women
  • those with recent ocular surgeries
  • systemic medications affecting tear film, or severe unrelated diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alvi Hospital

Mandi Bahāuddīn, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)