Evaluation of Safety and Effectiveness of Intra Ocular Lens
- Conditions
- Health Condition 1: H28- Cataract in diseases classified elsewhere
- Registration Number
- CTRI/2018/12/016626
- Lead Sponsor
- Appasamy Ocular devices Private ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method