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Comparing two fluorescein dyes in subjects undergoing dry eye evaluation for pre-refractive surgery workup

A comparative study of safety, efficacy and correlation with non-invasive break up time using two fluorescein dyes in subjects undergoing dry eye evaluation for pre-refractive surgery work up

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038197
Enrollment
100
Registered
2021-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H048- Other disorders of lacrimal system

Interventions

Intervention1: Fluorescein staining: Eye will be stained with fluorescein dye and FBUT will be calculated for patients during pre-refractive workup. Intervention2: BioFluoro Strips Staining: FBUT will

Sponsors

BioTech Vision Care Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Any patient presenting to refractive surgery clinic for refractive surgery clinic for refractive surgery work up within the age group of 20-40 years with normal ocular surface. 2. Clear corneas without scarring, opacities, or vascularization as determined by bio microscopic examination; normal puncta without punctal plugs or punctal stenosis; and the absence of any corneal disease or dystrophy 3. Able to give written consent form

Exclusion criteria

Exclusion criteria: 1. Any patient of known ocular surface abnormality or corneal abnormality 2. History of ocular surgery or corneal injury 3. Active infection or allergy 4. Conjunctival abnormality other than mild pinguecula 5. Current use of any ocular medication, including antihistamines 6. Use of artificial tear preparations 2 hours prior to examination 7. Use of any ocular ointment, swimming in chlorinated water or 24 hours prior to examination 8. Contact Lens wearers- Soft contact Lens 9. Patient on any ocular medications 10. Any patient having known hypersensitivity to Fluorescein dye 11. Any report of ocular pain. 12. Pregnant or Lactating Mothers

Design outcomes

Primary

MeasureTime frame
1. Fluorescein break-up time (FBUT) measurementsTimepoint: Immediately

Secondary

MeasureTime frame
1. Fluorescein Dye Disappearance Test 2. Safety endpoint through Subjective QuestionnaireTimepoint: Immediately, 10 minutes, 2 hours and 2 days post treatment

Countries

India

Contacts

Public ContactDr Vedant Murkey

Nethradhama superspeciality eye hospital

drvedant23@gmail.com7720092058

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026