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Comparison of three types of phacoemulsification machines for cataract surgery

Comparative clinical study of surgical performance of Quatera 700 with membrane based pump versus Centurion and Signature Pro phacoemulsification systems

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039296
Enrollment
180
Registered
2022-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: H25- Age-related cataract

Interventions

Intervention1: Quatera 700 : 60 eyes to be operated with this machine over 3 to 4 months Control Intervention1: Centurion: Phacoemulsification system Control Intervention2: Signature Pro: 60 eyes to b

Sponsors

CARL ZEISS MEDITEC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1)EPT 2)TPT 3)Chamber stability at various parameters 4)Fluid turnover per case 5)Time taken per case according to nucleus grade 6)Complications such as posterior capsular rupture,zonular dialysis, nucleus drop,vitreous loss,wound burn etc Timepoint: On the day of surgery

Secondary

MeasureTime frame
1)UCVA 2)IOP 3)Corneal clarity 4)AC reaction 5)IOL position 6)Endothelial cell densityTimepoint: Post operative day 1,14 and 6 months

Countries

India

Contacts

Public ContactDr Hemali Bhavsar

Nethradhama superspeciality eye hospital

bhavsarhemali691@gmail.com9033417827

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026