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

NCT06277349 | Completed DMC

• 1 other identifier: MAUV1005
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cornea; Astigmatism; Cataract

Keywords

multifocal; IOL; astigmatism; incision; cataract surgery; implant

Outcome Measures

Primary Outcomes (2)

• Composite scoring of unaided distance and near vision (monocularly)

  Measurement of uncorrected and best corrected visual acuity will be done using a back-lit EDTRS chart placed at 4m. Near and distance unaided and corrected visual acuity will be measured, measuring reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk) and contrast vision under photopic and mesopic conditions (Pelli-Robson Chart). Reading speed, reading acuity and critical print size monocularly (Salzburg Reading Desk). The Salzburg Reading Desk (SRD) is the prototype of a reading chart that measures reading speed and reading distance. Contrast and light conditions are preset and reading distance (+/- 0.2 cm), reading speed and their changes during the examination are measured. This ensures an objective evaluation of measurements under the same conditions at every follow-up.

  3 months

• Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon)

  Measurement of residual astigmatism will be derived from autorefraction with an autorefractor (Topcon) with mean reading of 5 consecutive measurements in IOL mode, a subjective refraction by an optometrist using trial lenses and the cross cylinder method. All these measurements are non-invasive, non-contact and readily used in daily clinical practice.

  3 months

Study Arms (2)

Non toric multifocal IOL combined with corneal incisional surgery

OTHER

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.

Device: Non-toric multifocal IOL

Toric multifocal IOL alone

OTHER

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.

Device: Toric multifocal IOL

Interventions

Toric multifocal IOL DEVICE

Implant of Multifocal toric intraocular lens only

Also known as: Toric Multifocal IOL (Rayner) - Model M-Flex T 588 or 638 - CE marked since January 2007

Toric multifocal IOL alone

Non-toric multifocal IOL DEVICE

Implant of non-toric multifocal lens plus incisional surgery

Also known as: Non-toric Multifocal IOL (Rayner) - Model M-Flex 630F - CE marked since 2006 (in routine use)

Non toric multifocal IOL combined with corneal incisional surgery

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead

MeSH Terms

Conditions

Corneal Diseases; Astigmatism; Cataract; Surgical Wound

Condition Hierarchy (Ancestors)

Eye Diseases; Refractive Errors; Lens Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial with intra-patient comparison (bilateral study), patients are either receiving implant of a multifocal toric IOL or implant of a standard multifocal IOL combined with limbal relaxing incisions.

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 26, 2024
• Study Start: March 4, 2009
• Primary Completion: January 4, 2011
• Study Completion: January 4, 2011
• Last Updated: March 13, 2024

Record last verified: 2024-03