Health Condition 1: H259- Unspecified age-related cataract
Conditions
Interventions
Intervention1: BIOVISION CTR (Capsular Tension Ring)
A. CTR implantation with reusable delivery system
Models: CTR11B, CTR12B, CTR13B, CTR14B: Duration of therapy as per below:
? Pre-operative Visit/
Sponsors
Grewal Eye Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients older than 12 years 2. Normal fundus examination 3. Patients for whom phacoemulsification is required of cataract surgery 4. Patients with axial length >28 mm, or more than 3 months had passed since Pars plana vitrectomy (PPV) 5. Patients with weak zonules along with any of this following conditions Inadequate zonular support Patients with the pseudo-exfoliation syndrome Trauma causing zonular dialysis Phacodonesis 6. Patients who are eligible for phacoemulsification alone or with CTR implants 7. Patients who are eligible for phacoemulsification alone or with CTR implants 8. Patient willing to participate and sign informed consent forms. 9. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study
Exclusion criteria
Exclusion criteria: 1. Presence of a torn or compromised capsular bag or significant, progressive pseudoexfoliation 2. Patients with retinitis pigmentosa, trauma, other intraocular surgeries than PPV, or connective tissue disorders 3. Patients with chronic uveitis 4. Patients with progressive eye disease (e.g. diabetic retinopathy, uncontrolled glaucoma) 5. Patients with preoperative complications prior to cataract surgery (e.g. vitreous body prolapse, haemorrhage) 6. Patients with perforated or damaged capsules 7. Patients with zonular damage larger than 4 clock hours 8. Zonular rupture >90º 9. Pregnancy (as stated by patient) and lactation 10. Patients with concurrent participation in another drug or medical device clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Refraction - Refractive prediction error - Measured as subjective refraction. Both spherical and astigmatism shall be measured by using phoropter.Timepoint: Time Frame: Pre-operative, 90 Days Post- operative surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Visual Acuity-UDVA - The visual acuity upto 90 ± 7 days post- operative surgery, measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Visual acuity measured by ETDRS chart. 2) Visual Acuity- BCDVA - The visual acuity upto 90 ± 7 days post- operative surgery, measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity. Visual acuity measured by ETDRS chart. 3) IOL Tilt • IOL Tilt - Measured by Pentacam 4) IOL Decentration - • IOL Decentration - Measured by Pentacam Timepoint: 1) Visual Acuity-UDVA -Time Frame: Pre-operative, 90 Days Post- operative surgery 2) Visual Acuity- BCDVA -Time Frame: Pre-operative, 90 Days Post- operative surgery 3) IOL Tilt and 4) IOL Decentration - Time Frame: 15 Days Post- operative surgery, 90 Days Post- operative surgery | — |
Countries
India
Contacts
Public ContactDr Sartaj Singh Grewal
Grewal Eye Institute
Outcome results
None listed