A comparison of intra- operative efficiencies and early post-operative outcomes of 2 phaco machines :Legion® Phaco System and Laureate® Phaco System
Phase 4
- Conditions
- Health Condition 1: H251- Age-related nuclear cataract
- Registration Number
- CTRI/2021/06/034388
- Lead Sponsor
- ICARE Eye Hospital Post Graduate Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Uncomplicated age-related cataracts- Nuclear Opalescence (NO) grade III (LOCS III classification)
2.Normal transparent cornea
3.Normal retina/fovea
Exclusion Criteria
1.Age less than 40 or more than 75
2.Complicated cataracts-Traumatic cataract/ Subluxated cataract/ Post Uveitis Cataract/ Posterior Polar cataract
3.Ocular structural abnormalities- Floppy Iris Syndrome/ Presence of small pupils
4.Diseases/interventions on the cornea -Presence of Corneal dystrophies/corneal scars/opacities, LASIK
5.Presence of anterior chamber abnormalities like iris coloboma/lens coloboma, peripheral anterior synechiae or peripheral iridotomy
6.Pre-existing Glaucoma/Uveitis
7.Diseases of the retina - Age related macular degeneration, Diabetic Retinopathy
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean difference in the Central Corneal Thickness(CCT) between the two groupsTimepoint: Pre operative and post operative day 1 CCT measurement
- Secondary Outcome Measures
Name Time Method Mean Balanced Salt Solution volume usage between the two groupsTimepoint: Intra operative;Mean case time difference between the two groupsTimepoint: Intra operative;Mean difference in Anterior segment inflammation between the two groupsTimepoint: post-operative day 1;Mean difference in Central Corneal Thickness (CCT) between the two groupsTimepoint: pre-operative and post-operative month-1;Mean difference in the Endothelial Cell Count(ECC) between the two groupsTimepoint: pre-operative and post-operative month-1;Mean ultrasound time difference between the two groupsTimepoint: Intra operative