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Comparing damage to corneal endothelium by different methods of removing the nucleus in cataract surgery

A comparison of corneal endothelial cell loss with different techniques of nucleus delivery in manual small incision cataract surgery - randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/050143
Enrollment
90
Registered
2023-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: H590- Disorders of the eye following cataract surgery

Interventions

Intervention1: Viscoexpression
Irrigating vectis
Phacosandwich: Viscoexpression- Nucleus is delivered by continuously injecting viscoelastic substance into Anterior chamber
Irrigating vectis- nucleus is delivered by hydroexpression with irrigating vectis
Phacosandwich- Nucleus is delivered by sandwiching nucleus between both wire vectis and Sinskey cannula Intervention2: Viscoexpression: Viscoexpression- Nucleus is delivered by continuously injecting
Intervention3: Irrigating vectis: Irrigating vectis- nucleus is delivered by hydroexpression with irrigating vectis
Intervention4: Phacosandwich: Phacosandwich- Nucleus is delivered by sandwiching nucleus between both wire vectis and Sinskey cannula Control Intervention1: NIL: NIL Control Intervention2: NIL: NIL

Sponsors

Mahatma Gandhi Medical college and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients undergoing surgery for uncomplicated senile cataract with preoperative lens grading of NO4NC4P4 or less by Lens Opacities Classification System III Classification (LOCS III)

Exclusion criteria

Exclusion criteria: 1.Patients with systemic/ ocular comorbid condition which is known to influence corneal endothelial cell count eg. Diabetes, Pseudoexfoliation 2. Pupil diameter less than 5mm after a full dilatation 3.Patients with intraoperative/ post operative complications which would be confounders in corneal endothelial cell count or would preclude imaging by specular microscopy like PC rent, dislocated IOL, iridodialysis, corneal edema, iridocyclitis

Design outcomes

Primary

MeasureTime frame
Comparing corneal endothelial cell loss following different techniques of nucleus delivery, that are most commonly used and establishedTimepoint: comparison done post operative day1 and post operative 6weeks—

Secondary

MeasureTime frame
Comparing corneal endothelial cell loss following manual small incision cataract surgeryTimepoint: comparison done post operative 6weeks—

Countries

India

Contacts

Public ContactFincy Mol

Mahatma Gandhi Medical College and Research Institute

swathin@mgmcri.ac.in9488540930

Outcome results

None listed

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