Evaluation of Safety and Effectiveness of Intra Ocular Lens

An Open-label, Prospective, Multicentre, Single arm, Clinical Study to evaluate the Safety and Effectiveness of Acryfold (An Intraocular Lens manufactured by Appasamy Ocular devices Private ltd., Puducherry) in subjects undergoing cataract surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2018/12/016626

Enrollment

350

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: H28- Cataract in diseases classified elsewhere

Interventions

Intervention1: Acryfold: Hydrophilic Acrylic Foldable Intraocular Lens Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: 1 Adult Male or Female Patients 2 Cataract 3 Calculated IOL is within the range of Investigational IOL 4 Clear Intraocular Media other than cataract 5 Signed Informed consent form

Exclusion criteria

Exclusion criteria: 1 Previous Intra ocular surgery or Corneal Surgery 2 Cataract with Astigmatism more than 1.30D 3 Pregnancy and Lactation 4 Concurrent participation in another investigational drug or device Investigation study 5 Instability of Keratometry or Biometry Measurements Subjects shall be discontinued when certain conditions are present at the time of Surgery, Including 1 Zonular Instability 2 Need for iris Implantation 3 Capsular Fibrosis or Other opacity 4 Inability to fixate IOL in desired position 5 Vitreous loss In such cases the subject shall be followed until the condition has stabilized

Design outcomes

Primary

Measure	Time frame
Intra Ocular Pressure Corneal Status Pupillary Block Retinal Detachment IOL Optic decentration IOL Optic tilt IOL Discoloration IOL Opacity Inflammation Like Anterior Chamber Cells and Anterior Chamber Flare Cystoid Macular Oedema Hypopyon and Endophthalmitis Status of Anterior and Posterior capsule If any other Adverse Events???Timepoint: POST OPERATIVE 1 to 2 day 7 to 14th day 30 to 60 days 120 to 180 days 330 to 420 days	—

Measure

Time frame

Intra Ocular Pressure Corneal Status Pupillary Block Retinal Detachment IOL Optic decentration IOL Optic tilt IOL Discoloration IOL Opacity Inflammation Like Anterior Chamber Cells and Anterior Chamber Flare Cystoid Macular Oedema Hypopyon and Endophthalmitis Status of Anterior and Posterior capsule If any other Adverse Events???Timepoint: POST OPERATIVE 1 to 2 day 7 to 14th day 30 to 60 days 120 to 180 days 330 to 420 days

—

Secondary

Measure	Time frame
1 Visual Acuity Uncorrected Distance Visual Acuity and Best Spectacle Corrected Distance Visual Acuity 2 Refraction- Subjective Spherical Timepoint: POST OPERATIVE 1 to 2 day 7 to 14th day 30 to 60 days 120 to 180 days 330 to 420 days	—

Countries

India

Contacts

Public ContactDr Uma Srinivasan

Appasamy Ocular Devices Pvt Ltd

amu_s@yahoo.com9381230979

Outcome results

None listed

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