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Effectiveness of Ophthalmic Viscosurgical Devices on corneal surface for Postoperative ocular discomfort and dry eye in cataract surgery Patients

Effect of visco elastic devices Tea on eye discomfort and dry eye : A blinded Randomized Controlled Trial in catract patient

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260611001
Enrollment
70
Registered
2026-06-11
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Cataract Dry Eye Syndrome Eye discomfort Ocular Irritation Corneal Edema post op cataract surgery Phacoemulsification Viscoelastic Dry Eye Syndromes Cataract

Interventions

Topical application of leftover Ophthalmic Viscoelastic Device (OVD) from the surgery to coat the corneal surface after wound closure and prior to the removal of the eye speculum. This reversible inte
Experimental Drug,Active Comparator Drug
Application of viscoelastic agents on corneal surface ,Balance salt solution (Standard care)

Sponsors

King Chulalongkorn Memorial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or older. For patients aged over 60 years, a passing score on a cognitive impairment assessment is required. Cognitive function will be assessed using the Thai version of the 6-Item Cognitive Impairment Test 6CIT. Participants must score 0 to 7 normal cognitive function to be eligible. Those scoring less 8 significant cognitive impairment will be excluded. 2. Diagnosed with cataracts. 3. Scheduled for their first cataract surgery. 4. No hearing or communication impairments. 5. Scheduled for surgery at the Ambulatory Surgery Unit, Bhumisiri Building 8B, King Chulalongkorn Memorial Hospital. 6. The contralateral eye is not diagnosed with blindness. 7. Willing to participate in the study and reachable by telephone.

Exclusion criteria

Exclusion criteria: 1. Occurrence of intraoperative complications 2. Presence of the following comorbidities Diabetes Mellitus Stevens Johnson Syndrome, Sjogren s Syndrome or Meibomian Gland Dysfunction 3. History of contact lens use 4. History of prior refractive surgery. 5. Currently receiving antidepressant medication. 6. History of dry eye disease.

Design outcomes

Primary

MeasureTime frame
eye discomfort pre op,post op day 1,7,14 measured via a 11-point Numeric rating scalr where scores range fron 0 (no irrigation/discomfort) to 10 (worst possible irrigation/discomfort)),dry eye symtoms pre op,post op day 1,7,14 evaluted using the ocular surface disease Index (OSDI) questionnaire. The total score ranges from 0 to 100, 0-12 normal,13-22 mild,23-32 moderted, 33-100 severe

Secondary

MeasureTime frame
corneal clarity pre op,post op day 1,7,14 evaluated via slit lamp and graded on a binary scale 0:clear conea, 1:not clear/edema

Countries

Thailand

Contacts

Public ContactWarangkana Kongcharoen

King chulalongkorn memorial hospital

pimwarangkana2536@gmail.com0914029522

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026