Evaluation of Safety and Effectiveness of Supraphob Intra Ocular lens
Phase 4
- Conditions
- Health Condition 1: H28- Cataract in diseases classified elsewhere
- Registration Number
- CTRI/2018/12/016513
- Lead Sponsor
- Appasamy Ocular devices Private ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
1 Previous Intra ocular surgery or Corneal Surgery.
2 Cataract with Astigmatism more than 1.30D
3 Traumatic Cataract
4 Pregnancy and Lactation
5 Concurrent participation in another investigational drug or device Investigation study
6 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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intra Ocular Pressure <br/ ><br>Corneal Status <br/ ><br>Pupillary Block <br/ ><br>Retinal Detachment <br/ ><br>IOL Optic Decentration <br/ ><br>IOL Optic tilt <br/ ><br>IOL Discoloration <br/ ><br>IOL Opacity <br/ ><br>Inflammation Like Anterior Chamber Cells and Anterior Chamber Flare Cystoid Macular Oedema <br/ ><br>Hypopyon and Endophthalmitis <br/ ><br>Status of Anterior and Posterior capsule <br/ ><br>If any other Adverse Events???Timepoint: POST OPERATIVE <br/ ><br>1 to 2 day <br/ ><br>7 to 14th Day <br/ ><br>30 to 60 Days <br/ ><br>120 to 180 Days <br/ ><br>330 to 420 Days.
- Secondary Outcome Measures
Name Time Method 1 Uncorrected Distance Visual Acuity and Best Spectacle Corrected Distance Visual Acuity <br/ ><br>2 Refraction- Subjective Spherical <br/ ><br>Timepoint: POST OPERATIVE <br/ ><br>1 to 2 day <br/ ><br>7 to 14th Day <br/ ><br>30 to 60 Days <br/ ><br>120 to 180 Days <br/ ><br>330 to 420 Days.