Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery

Moorfields Eye Hospital NHS Foundation Trust

Status: Completed

Conditions: Cataract; Astigmatism; Cornea

Treatments: Device: Toric multifocal IOL; Device: Non-toric multifocal IOL

Study type: Interventional

Funder types: Other

Identifiers

NCT06277349

MAUV1005

Details and patient eligibility

About

The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery.

Full description

This is a randomized controlled trial with intra-patient comparison, 60 eyes (30 patients) with cataract and corneal astigmatism of 1.00 to 2.50 D (doctrine) took part in the trial. The trial assessed the efficacy of multifocal IOL (intraocular lens) with corneal pre-existing astigmatism and compare the outcomes of a multifocal toric IOL or a standard multifocal IOL combined with limbal relaxing incisions.

Enrollment: 30 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bilateral cataract and be planning to have both eyes operated on.
• Age 21 and older
• Have cataracts that allow IOL master biometry
• Regular corneal astigmatism 1.00 up to 2.50 D
• Difference of corneal astigmatism in both eyes to be equal to or less than 0.75D
• written informed consent to surgery and participation in the study
• Speak English

Exclusion criteria

• Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
• Irregular corneal astigmatism on Pentacam topography

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Non toric multifocal IOL combined with corneal incisional surgery

Other group

Description:

Non-toric Multifocal IOL (Rayner) - Model M-Flex 630F - CE marked since 2006 (in routine use). Surgery is performed under topical anaesthesia. Preoperatively, the horizontal meridian will be marked in the sitting position with a blue marking pen or insulin syringe at the limbus. The temporal self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed as standard procedure. Corneal limbal relaxing incisions (LRI) according to the Donnenefeld nomogram will be performed combined with standard non-toric multifocal IOL.

Treatment:

Device: Non-toric multifocal IOL

Toric multifocal IOL alone

Other group

Description:

Toric Multifocal IOL (Rayner) - Model M-Flex T 588 or 638 - CE marked since January 2007. Surgery is performed under topical anaesthesia. Preoperatively, the horizontal meridian will be marked in the sitting position with a blue marking pen or insulin syringe at the limbus. The temporal self sealing incision, injection of viscoelastic substance, capsulorhexis, phacoemulsification, irrigation/aspiration of cortical material and injection of viscoelastic substance into the capsular bag are performed as standard procedure. The multifocal toric IOL will be implanted.

Treatment:

Device: Toric multifocal IOL