A comparative clinical study to evaluate the safety and performance of capsular tension ring.

Phase 4

Recruiting

• Conditions: Unspecified age-related cataract,

• Registration Number: CTRI/2023/03/050397
• Lead Sponsor: Grewal Eye Institute

Brief Summary

**Titleof Study:**A prospective,controlled randomized, comparative, singlecenter, clinical study to evaluate performance and safetyof implanted Capsular Tension Ring (CTR) and CTR delivery system.

**Objectives:**

Primary Objectives:

To evaluate the performance of Capsular Tension Ring(CTR) against controlled group (without CTR) to check clinical outcome ofrefractive prediction error.

SecondaryObjectives:

For Capsular Tension Ring:

·      To evaluatethe performance of Capsular Tension Ring against controlled group (without CTR)to check clinical outcome of visual acuity.

·      To evaluatesafety of Capsular Tension Ring implanted group and controlled group (withoutCTR).

ForDelivery System:

To check the safety and performance of two delivery systems for CTRimplant.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-15
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• 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.
• Patient willing to participate and sign informed consent forms.
• 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

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.	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.	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.

Trial Locations

Locations (3)

Grewal eye institute; 🇮🇳 Chandigarh, CHANDIGARH, India

Sankara eye Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Tejas eye Hospital; 🇮🇳 Surat, GUJARAT, India

Grewal eye institute

🇮🇳Chandigarh, CHANDIGARH, India

Dr Sartaj Singh

Principal investigator

9779716169

sartajg@gmail.com