A comparative clinical study to evaluate the safety and performance of capsular tension ring.
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Registration Number
- CTRI/2023/03/050397
- Lead Sponsor
- Grewal Eye Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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. <br/ ><br>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. <br/ ><br>3)IOL Tilt <br/ ><br>•IOL Tilt - Measured by Pentacam <br/ ><br>4)IOL Decentration - <br/ ><br>•IOL Decentration - Measured by Pentacam <br/ ><br>Timepoint: 1)Visual Acuity-UDVA -Time Frame: Pre-operative, 90 Days Post- operative surgery <br/ ><br>2)Visual Acuity- BCDVA -Time Frame: Pre-operative, 90 Days Post- operative surgery <br/ ><br>3)IOL Tilt and 4)IOL Decentration - Time Frame: 15 Days Post- operative surgery, 90 Days Post- operative surgery <br/ ><br>