Comparison of three types of phacoemulsification machines for cataract surgery
- Conditions
- Health Condition 1: H25- Age-related cataract
- Registration Number
- CTRI/2022/01/039296
- Lead Sponsor
- CARL ZEISS MEDITEC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1)nuclear or corticonuclear cataract of grade 1 to 4 according to LOCS III scale
2)suitable to undergo phacoemulsification with foldable intraocular lens implantation within IOL power range of +16 to +24 D
3)willing and able to understand/sign a written informed consent
1)complex cases of cataract like morgagnian,intumescent,posterior polar,phacomorphic glaucoma,traumatic,subluxation and uveitic cataracts
2)poorly dilating pupils or patients on alpha adrenergic antagonists for benign prostate hyperplasia requiring pupil expansion devices intra operatively
3)corneal diseases like keratoconus,pellucid marginal degeneration,leucomatous corneal scars, corneal degeneration
4)planned multiple procedures at the time of surgery or during the course of the study(e.g. LASIK,LRI etc)
5)previous intraocular or corneal surgery of any kind
6)severe optic nerve and retinal disorders
7)immunocompromised or systemic conditions which may increase the operative risk or confound the result of this investigation
8) pregnant or lactating females
9)currently participating in another drug or device clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)EPT <br/ ><br>2)TPT <br/ ><br>3)Chamber stability at various parameters <br/ ><br>4)Fluid turnover per case <br/ ><br>5)Time taken per case according to nucleus grade <br/ ><br>6)Complications such as posterior capsular rupture,zonular dialysis, nucleus drop,vitreous loss,wound burn etc <br/ ><br>Timepoint: On the day of surgery <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1)UCVA <br/ ><br>2)IOP <br/ ><br>3)Corneal clarity <br/ ><br>4)AC reaction <br/ ><br>5)IOL position <br/ ><br>6)Endothelial cell densityTimepoint: Post operative day 1,14 and 6 months