Better corneal endothelium cell protection during cataract surgery in Type 2 Diabetes Mellitus patients using different Ophthalmic viscosurgical devices

Evaluation of outcome of two different Ophthalmic viscosurgical devices 3 percent Sodium Hyaluronate and 4 percent Chondroitin sulphate vs 2 percent Hydroxy propyl methyl cellulose on endothelial cell count in Phacoemulsifiction cataract surgery in Diabetics - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094198

Enrollment

Registered

2025-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 3% Sodium Hyaluronate and 4% Chondroitin Sulphate,2% Hydroxy Propyl Methyl Cellulose: Evaluate the outcomes of two interventional devices on Endothelial cell count in Phacoemulsificatio

Eligibility

Inclusion criteria

Inclusion criteria: Grade of cataract- Nuclear sclerosis 1,2,3 and posterior subcapsular cataract 1,2,3,4 cortical cataract 1,2,3,4 by Lens Opacities Classification System(LOCS 3) Pre operative Specular count >2000 cells/mm2 Uneventfull cataract surgery Diagnosed with Type2 DM

Exclusion criteria

Exclusion criteria: Grade of cataract-Nuclear Sclerosis 4,5,6 posterior subcapsular cataract 5 cortical cataract 5 (Lens Opacities Classification System Grading 3) Corneal pathologies like fuchs endothelial dystrophy Ocular pathology like Uveitis, pseudoexfoliation, glaucoma Trauma Previous eye surgery Small rigid pupil(less than 5 mm) Subluxated cataract Complicated cataract Study subjects lost to follow-up

Design outcomes

Primary

Measure	Time frame
Endothelial Cell Count decrease to be evaluated in both groups of Ophthalmic Viscosurgical DeviecesTimepoint: Endothelial Cell Count decrease to be evaluated in both groups of Ophthalmic Viscosurgical Devieces at baseline, 1 week,1 month,3 months	—

Secondary

Measure	Time frame
Central corneal thickness increase to be evaluated in both groups of Ophthalmic viscosurgical devicesTimepoint: Central corneal thickness increase to be evaluated in both groups of Ophthalmic viscosurgical devices at baseline , 1 week,1 month,1 month	—

Countries

India

Contacts

Public ContactNALIN SAH

SANKARA EYE HOSPITAL GUNTUR

aneesfatima@sankaraeye.com

Outcome results

None listed

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