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This is a hospital based comparison study and will compare two types of lenses implanted in the eye after cataract removal.

Safety and Efficacy of Single Piece yellow tinted hydrophobic acrylic intraocular lens (Supraphob Bby) and Single Piece hydrophilic acrylic intraocular lens (Acryfold) - A Hospital based comparative prospective study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/12/016638
Enrollment
272
Registered
2018-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H25-H28- Disorders of lens

Interventions

Control Intervention1: Hydrophobic and Hydrophilic intraocular lens will be compared: Hydrophobic (Supraphob BBY) compared with Hydrophilic acrylic ( Acryfold ) intraocular lenses for visual outcome a

Sponsors

Dr Arokiam John Bosco
Lead Sponsor
M/S Appasamy Ocular Devices (P) Ltd.
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Cataract amenable to phacoemulsification and foldable intraocular lens implantation Patients with clinically diagnosable cataract Patient willingness to participate in the study

Exclusion criteria

Exclusion criteria: Patients with visual loss not due to cataract Patients with anterior and posterior segment pathology Patients with clinical conditions were foldable lenses will be contraindicated eg uveitic cataract patients below fifty and above seventy five years Patients not willing to participate in the study and with poor compliance

Design outcomes

Primary

MeasureTime frame
To compare the safety and efficacy of single piece yellow tinted hydrophobic acrylic intraocular lens (supraphob Bby) with hydrophilic acrylic intraocular lens (Acryfold) following cataract extraction in adults. 1. To compare visual outcome by visual acuity, contrast sensitivity and refractive stability, for measuring efficacy. 2. To compare adverse events, glare, posterior capsular opacification, for measuring safety parameters. 3. To compare patient satisfaction.Timepoint: After implantation post operative follow up will be performed on Day1, Day3, Day7, Day 30(firstmonth), Day 60(secondmonth), Day 180(sixth month)and Day360(post operative one year follow up)

Secondary

MeasureTime frame
to compare visual and clinical performance of both the intraocular lensesTimepoint: follow up over a period of two years

Countries

India

Contacts

Public ContactDr Arokiam John Bosco

Indira Gandhi Government General Hospital and Post Graduate Institute puducherry

arokiamjohnbosco@gmail.com8903727097

Outcome results

None listed

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