Prospective, Controlled, Randomized, Masked Unilateral or Bilateral implantation, Single Centre, Clinical investigation study to evaluate Safety and Performance of EDOF (Extended Depth of Focus) IOL (Omni Lens Pvt Ltd) in patients who require EDOF IOL implantation during routine cataract Surgery.
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- 1. Best-Corrected distance visual acuity(CDVA)
Study Overview
Brief Summary
Prospective, Controlled, Randomized, Masked Unilateral or Bilateral Implantation, Single Centre Clinical Investigational study of EDOF Hydrophilic Acrylic Foldable IOL (Omni Lens Pvt.Ltd.) in patients who require EDOF Implantation during routine cataract surgery.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Cataract (Unilateral/Bilateral) 2.Calculated EDOF IOL power is within the range of the Study device i.e. 8 to 30 D (+3.00D) 3.The patient or his/her legally authorized representative (if applicable) agrees to provide written informed consent.
- •4.Clear intraocular media other than cataract 5.The patient is willing to comply with protocol specified follow-up evaluations.
- •#If any of the above criteria is answered ‘No’, the subject may not be enrolled in the study.
Exclusion Criteria
- •Previous intraocular or corneal surgery
- •Traumatic cataract and/or existing inflammation
- •Pregnancy or lactation
- •Concurrent participation in another drug or device investigation
- •At the time of surgery conditions such as zonular instability, need for iris manipulation, capsular fibrosis or other opacity and inability to fixate EDOF IOL in desired position.
- •Instability of keratometry or biometry measurements
- •Irregular astigmatism
- •History of intraocular Inflammation
- •Subjects who may be reasonably expected to require secondary surgical intervention at any time during the investigation (other than YAG capsulotomy).
- •Gonioscopy Abnormalities
- •More than 1 D of pre-operative corneal astigmatism
- •Minor under the age of 18
- •Those who are participating in other clinical trials of drugs or medical devices.
- •# If any of the above criteria is answered ‘YES’, the subject may not be enrolled in the study.
Outcomes
Primary Outcomes
1. Best-Corrected distance visual acuity(CDVA)
Time Frame: 1. Best-Corrected Distance Visual Acuity (CDVA) [Time frame: At Baseline, 1 week,4 weeks and 18 weeks) | 2.Distance –corrected Intermediate visual Acuity (DCIVA) [Time frame: 4weeks and 18 weeks] | 3.Distance –corrected Near visual Acuity (DCNVA) [Time frame: 4 weeks and 18 weeks]
2. Distance -corrected intermediate visual acuity(DCIVA)
Time Frame: 1. Best-Corrected Distance Visual Acuity (CDVA) [Time frame: At Baseline, 1 week,4 weeks and 18 weeks) | 2.Distance –corrected Intermediate visual Acuity (DCIVA) [Time frame: 4weeks and 18 weeks] | 3.Distance –corrected Near visual Acuity (DCNVA) [Time frame: 4 weeks and 18 weeks]
3. Distance-corrected near visual acuity(DCNVA)
Time Frame: 1. Best-Corrected Distance Visual Acuity (CDVA) [Time frame: At Baseline, 1 week,4 weeks and 18 weeks) | 2.Distance –corrected Intermediate visual Acuity (DCIVA) [Time frame: 4weeks and 18 weeks] | 3.Distance –corrected Near visual Acuity (DCNVA) [Time frame: 4 weeks and 18 weeks]
Secondary Outcomes
- 1. Depth of focus curve Test(2. Adverse event rates)
Investigators
Dr Uday R Gajiwala
Divyajyoti Trust- Tejas Eye Hospital