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Completed

NCT Number: NCT06277349

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toric multifocal IOL

Device

Implant of Multifocal toric intraocular lens only

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

Non-toric multifocal IOL

Device

Implant of non-toric multifocal lens plus incisional surgery

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

Primary outcomes

  1. Composite scoring of unaided distance and near vision (monocularly)

    Time frame: 3 months

    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.

  2. Residual astigmatism evaluation by Subjective Refraction and autorefraction (Topcon)

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 26, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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