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evaluating a new cystitome maker in terms of its repeatability and its use in making capsulorhexis in Phacoemulsification

Repeatability and validation of a new cystitome maker for capsulorhexis in phacoemulsification

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/044241
Enrollment
100
Registered
2022-07-22
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: H251- Age-related nuclear cataract

Interventions

Intervention1: Ganesh cystitome maker: Cystitome made by Ganesh cystitome maker Control Intervention1: Needle holder group: Cystitome made by needle holder

Sponsors

Nethradhama Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex, aged between 40- 75 years diagnosed with nuclear or cortico-nuclear cataract of grade I- IV according to the Lens Opacity Classification System III (LOCS III) scale Suitable to undergo phacoemulsification with foldable Intraocular Lens (IOL) implantation within an IOL power range of +16 to +24 D Willing and able to understand/sign a written informed consent document

Exclusion criteria

Exclusion criteria: LOCS-III Nuclear sclerosis grade 4+ Complex cases of cataract such as mature and intumescent, morgagnian, posterior polar, phacomorphic glaucoma, uveitic cataracts, traumatic and subluxated cataracts Poorly dilating pupils or patients on alpha adrenergic antagonists for benign prostrate hyperplasia (BPH) requiring pupil expansion devices intra-operatively Corneal diseases such as keratoconus, pellucid marginal degeneration, leucomatous corneal scars, corneal degenerations Planned multiple procedures at the time of surgery or during the course of the study (e.g., LASIK, LRI, etc.) Previous intraocular or corneal surgery of any kind Severe optic nerve and retinal disorders (e.g., glaucomatous cupping, optic atrophy, macular degeneration, proliferative diabetic retinopathy, retinal detachment) Immunocompromised or systemic conditions which may increase the operative risk or confound the result of this investigation Female patients who are pregnant or lactating Currently participating in another drug or device clinical trial Other protocol-defined exclusion criteria may apply

Design outcomes

Primary

MeasureTime frame
1)repeatability 2)satisfaction grading score of the surgeon will be measured Timepoint: baseline

Secondary

MeasureTime frame
statical analysisTimepoint: 1 day

Countries

India

Contacts

Public ContactDr Sheetal Brar

Nethradhama Superspeciality Eye Hospital

brar_sheetal@yahoo.co.in9591002092

Outcome results

None listed

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