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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06277349
• Other study ID #: MAUV1005
• Status: Completed
• Phase: N/A
• Start date: March 4, 2009
• Est. completion date: January 4, 2011

Study information

• Verified date: March 2024
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 4, 2011
• Est. primary completion date: January 4, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Cornea

Intervention

Device:
• Toric multifocal IOL
Implant of Multifocal toric intraocular lens only
• Non-toric multifocal IOL
Implant of non-toric multifocal lens plus incisional surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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