Clinical Evaluation of Toric Intraocular Lens Made by Aurolab (TORICIOL)

Aurolab

Status and phase: Unknown; Phase 4

Conditions: Astigmatism

Treatments: Device: Experimental - Toric Intraocular lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT01396616

1PN1011037

Details and patient eligibility

About

The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL.

Full description

Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery.

Further, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40 to 65
• Senile cataract
• Posterior Sub Capsular Cataract (PSCC)
• Astigmatism 1.25 D or more
• Residence within 100 kms of Madurai

Exclusion criteria

• Traumatic & Complicated cataract
• Poor mydriasis
• Amblyopia
• Severe Pseudo exfoliation (PXF)
• Dense posterior polar cataract (PPC)
• One eyed patients
• Uveitis
• Corneal pathology / Scar
• Retinal Pathology contributing to visual loss
• Intraoperative complication like PC rupture, Zonular dialysis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Single Arm

Experimental group

Description:

The enrolled subject will be implanted with Toric IOL manufactured by AuroLab

Treatment:

Device: Experimental - Toric Intraocular lenses