Clinical Outcomes and Rotational Stability of EDOF Toric lens using two Different sized IOLs

This prospective interventional single center study will be approved by the Institutional Ethics Committee of Nethradhama Super Speciality Eye Hospital Bangalore and will be conducted in accordance with the tenets of the Declaration of Helsinki. Verbal and written informed consent will be obtained from all patients participating in the study.

Preoperatively all patients will undergo a detailed ophthalmic evaluation including assessment of visual acuity for distance intermediate at 80 cm 60 cm and 40 cm and near at 33 cm using the ETDRS chart. Intraocular pressure measurement will be performed using non contact tonometry. Slit lamp examination keratometry white to white measurement A scan biometry using IOLMaster 700 Zeiss Meditec Germany Scheimpflug based corneal topography using Pentacam Oculus specular microscopy using Tomey Keeler and dilated fundus examination will be carried out for all patients.

Intraocular lens selection will be done using toric extended depth of focus intraocular lenses of two different sizes provided by the manufacturer as per study protocol.

All surgeries will be performed under topical anesthesia by an experienced surgeon. Patients undergoing femtosecond laser assisted cataract surgery will undergo capsulotomy using a femtosecond laser platform. A temporal clear corneal incision of 2.8 mm will be made followed by a continuous curvilinear capsulorhexis of approximately 5.0 to 5.5 mm ensuring adequate overlap of the intraocular lens optic. Standard hydrodissection and hydrodelineation will be performed and the crystalline lens will be removed using routine phacoemulsification techniques. The selected toric extended depth of focus intraocular lens will be implanted into the capsular bag and initially rotated close to the intended axis. After complete removal of viscoelastic material from the anterior chamber and behind the lens the intraocular lens will be precisely aligned with the marked axis using the Callisto system Zeiss Meditec Germany. Wound hydration will be performed to ensure a watertight closure.

Postoperatively all patients will receive standard topical antibiotic therapy with moxifloxacin topical steroids with prednisolone acetate one percent and a non steroidal anti inflammatory drug nepafenac. Follow up visits will be scheduled on postoperative day one day fifteen and three months.

Postoperative evaluation will include monocular and binocular visual acuity assessment for distance intermediate at 80 cm 60 cm and 40 cm and near at 33 cm using the ETDRS chart refraction and monocular and binocular defocus curves ranging from plus three diopters to minus three diopters. Slit lamp examination will be performed on day one day fifteen and three months after surgery. Dilated fundus examination and slit lamp photography to assess intraocular lens rotational stability will be conducted on day fifteen and three months. Patient satisfaction questionnaire will be administered on day fifteen.

Any complications protocol deviations or serious adverse events will be reported to the Institutional Ethics Committee within forty eight hours of occurrence.