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Evaluation of tear film parameters on diabetic patients undergoing small incision cataract surgery

Comparative evaluation of tear film parameters by using ophthalmic viscosurgical devices intraoperatively on ocular surface in diabetic patients undergoing small incision cataract surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022251
Enrollment
138
Registered
2019-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H259- Unspecified age-related cataract

Interventions

Intervention1: Ophthalmic viscosurgical devices: Hydroxypropyl methylcellulose 2% will be used on the ocular surface, to wet the cornea during cataract surgery. Intervention2: balanced salt solution (

Sponsors

Hyderabad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Type 2 Diabetes mellitus in the age group 40-70 yrs attending the Comprehensive services, on anti-diabetic treatment(oral hypoglycemics or Insulin), and diagnosed with cataract formation on ocular examination will be eligible for inclusion in the study.

Exclusion criteria

Exclusion criteria: The exclusion criteria will include any factor which may affect the tear film parameters like 1.Patients with dry eye symptoms: foreign body sensation, stinging, redness, burning, scratchy sensation, excessive tearing/watery eyes, stringy mucus in or around the eyes, sensitivity to light, and eye fatigue. 2.Pterygia 3.Contact lens wearers 4. Use of topical eye drops 1 month prior to surgery(steroids, NSAIDS, artificial tears,anti-glaucoma medications) 5.Co-existing ocular disorders (glaucoma, corneal opacity, uveitis) 6.History of systemic illness (Stevens-Johnson syndrome, Sjogrenâ??s syndrome, thyroid eye disease, and connective tissue disorders) 7. Pregnancy 8. Any previous ocular surgery 9.Sensitivity to any medications used during the perioperative period 10.Poor co-operation in diagnostic tests or non-compliance to follow-up 11.Participation in other clinical trials at the time of visit 12.Patients undergoing any intraoperative complications during the cataract surgery like nucleus drop, posterior capsular rupture, any trauma to iris requiring suturing etc. will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
OSDI Score at 1 month post operatively Timepoint: OSDI Score at 1 month post operatively

Secondary

MeasureTime frame
1. Subjective dry eye (DE) questionnaire 2. Schirmer I test with anaesthesia 3. Tear film break up time (TBUT) 4. Fluorescein staining pattern Timepoint: none

Countries

India

Contacts

Public ContactDr Vaisakhi Prasannan

L V Prasad Eye Institute

sagarika@lvpei.org06742653001

Outcome results

None listed

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