Health Condition 1: Z961- Presence of intraocular lens
Conditions
Interventions
Intervention1: Toric Hydrophilic Acrylic Intraocular Lens (Omni Lens Pvt. Ltd.): Dose: NA,
Frequency: NA,
Route of Administration: Intraocular,
Duration of Therapy: One time insertion.
Control Inter
Sponsors
Omni Lens Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient aged greater than or equal to 40 at the time of enrolment 2. A patient who receive Toric Hydrophilic Acrylic IOL (Omni Lens Pvt. Ltd.) as per the instruction mentioned in instructions for use (IFU) of the study device during routine cataract surgery 3. Clear intraocular media other than cataract 4. Calculated IOL power is within the range of the Study device 5. Corneal astigmatism greater than equal to 0.75 D and less than equal to 6.00 D 6. Dilated pupil size large enough to visualize TIOL axis markings postoperatively 7. The patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent 8. The patient is willing to comply with protocol specified follow-up Evaluations
Exclusion criteria
Exclusion criteria: 1. Patient with contraindications for TIOL mentioned in the IFU of the study device 2. Previous intraocular or corneal surgery 3. Traumatic cataract 4. Pregnancy or lactation 5. Instability of keratometry or biometry measurements 6. Irregular astigmatism 7. Currently participating in another clinical study with experimental drugs or devices 8. Unsuitable for study participation for any other reason, as determined by Investigators clinical judgment (reason to be documented on CRF) 9. Active SARS-CoV-2 infection known to Patient at the time of enrolment in the study/ patients having signs and symptoms of SARSCoV- 2 infection at the time of enrolment Patients shall be discontinued when certain conditions are present at the time of surgery, including:1 zonular instability; need for iris manipulation; capsular fibrosis or other opacity and inability to fixate IOL in the desired position. In such cases, the patient shall be followed until the condition has stabilized.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best-Corrected Distance Visual Acuity (BCDVA)Timepoint: [Time frame: visit 4] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in cylindrical power of the eye [Time frame: visit 4, visit 5] 2. Rotational stability [Time frame: visit 4] - Rotational stability will be evaluated by IOL axis mark rotation at visit 4. 3. Best-Corrected Distance Visual Acuity (BCDVA) compared to historical Data of EN ISO 11979-7:2018, Annex E (Table E.3 and E.4) [Time frame: Pre-op, visit 2, visit 3, visit 4, visit 5] 4. Adverse event rates [Time frame: Baseline, visit 1, visit 2, visit 3, visit 4, visit 5] Timepoint: [Time frame: visit 4] | — |
Countries
India
Contacts
Public ContactDr Jatin Soni
Eupraxia Centre For Clinical Excellence LLP
Outcome results
None listed