Health Condition 1: null- Patients who have undergone cataract surgery with implantation of Vivinex iSert® XY1 Intraocular lens.
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Dr Madhu Shekhar
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ability to understand and willingly provide informed consent for study participation. 2.Male or female patients of >=50 to 3.Patients willing to attend all study follow-up visits and comply with study protocol. 4.Have Life expectancy of at least 3 years or above from the time of study participation.
Exclusion criteria
Exclusion criteria: 1.Patients having any pre-existing corneal pathology. 2.Patients with any pre-existing macular pathology that is likely to affect the post-operative BCVA. 3.Any other co-existing ocular co morbidities besides cataract that are likely to affect the post-operative BVCA. 4.Participation in this study with the other eye. 5.Female participants who have attained the age of 50 years or more but have/have not attained menopause and are pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes. 6.Concurrent participation or participation within 30 days prior to visit 1 (post-operative/discharge), in any other clinical trial with an investigational product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Post-Operative Capsular Opacification (PCO)Timepoint: To be assessed at Week 6, Month 6, Month 12, Month 24 and Month 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Contrast SensitivityTimepoint: To be assessed at Week 6, Month 6, Month 12, Month 24 and Month 36;Device Related Adverse EventsTimepoint: Post Implantation till Month 36;IOL GlisteningTimepoint: To be assessed at Week 6, Month 6, Month 12, Month 24 and Month 36;Need for CapsulotomyTimepoint: Requirement of capsulotomy will be assessed at Week 6, Month 6, Month 12, Month 24 and Month 36;Ocular AberrationsTimepoint: To be assessed at Week 6, Month 6, Month 12, Month 24 and Month 36;Patient Reported Outcome for Ocular Symptoms and SatisfactionTimepoint: Pre-Operative Medical Record (Medical History)followed by Post Operative Discharge (Visit 1/Day 1), Week 1, Week 6, Month 6, Month 12, Month 24 and Month 36;Visual Acuity (UDVA & CDVA)Timepoint: Pre-Operative Medical Record (Medical History)followed by Post Operative Discharge (Visit 1/Day 1), Week 1, Week 6, Month 6, Month 12, Month 24 and Month 36 | — |
Countries
India
Contacts
Public ContactSubhash S
Aravind Eye Hospital
Outcome results
None listed