Toric Intraocular Lenses for Cataract Patients in the NHS

Cataract Clinical Trial

Official title:

Randomised, Controlled Study Comparing Use of "Off the Shelf" Toric Lenses, With Set Cylindrical Corrections (2.00D or 4.00D) and Combined Limbal Relaxing Incisions and/or Off-axis Lens Rotation, With Fully Targeted Toric Lens Correction.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04122651
• Other study ID #: 265865
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 14, 2019
• Est. completion date: August 2020

Study information

• Verified date: October 2019
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Khayam Naderi, MBBS BSc MA
• Phone: 020 7188 7188
• Email: khayam.naderi[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess visual performance, refractive outcome, and patient satisfaction with the use of "off the shelf" toric lenses, with a set cylindrical correction of 2.00 or 4.00 diopters, and combined limbal relaxing incisions and/or off-axis intraocular lens rotation, compared to fully targeted toric intraocular lens correction.

Description:

The aim of this study is to evaluate a simplified, more cost-effective procedure for the use of toric intraocular lenses, with a focus on suitability for NHS cataract surgery. This study will involve the use of standard, "off-the-shelf" toric lenses rather than having them specifically tailored and ordered for each individual patient. Eligible participants (>1.25 D of corneal astigmatism) will be randomised, receiving a toric IOL with either a 2.00 or 4.00 diopter (D) correction, depending on the degree of pre-operative astigmatism, or a toric IOL individually tailored to and ordered for each patients' precise degree of corneal astigmatism. With the "off the shelf" toric IOL group the correction of the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions LRIs and/or off axis rotation of the toric IOL (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient. The clinical outcome will then be measured and compared between the 2 groups. Independent safety monitoring will be performed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Bilateral or unilateral cataracts requiring surgical intervention

2. Age over 18 years

3. Able to understand informed consent and the objectives of the trial

4. Not pregnant, not breast feeding

5. No previous eye surgery

6. Corneal astigmatism greater than 1.5 diopters in one eye.

Exclusion Criteria:

1. age-related macula degeneration

2. glaucoma

3. previous retinal vascular disorders

4. previous retinal detachment or tear

5. any neuro-ophthalmological condition

6. any inherited retinal disorder or pathology

7. previous strabismus surgery or record of amblyopia

8. previous TIA, CVA or other vaso-occlusive disease

9. already enrolled in another study

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Cornea

Intervention

Procedure:
• 'Off the shelf' toric lens
'Off the shelf' toric lens (either 2.00D or 4.00D) and combined limbal relaxing incisions and/or off-axis inttaocular lens rotation
• Tailored Toric lens
Fully targeted toric intraocular lens correction for corneal astigmatism

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	City, University of London, King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuities	Corrected and uncorrected Logmar Visual Acuities	6 months
Primary	Refractive Error		6 months
Secondary	Intraoperative and post operative complications		0 day-6 months
Secondary	Patient Satisfaction	Patient satisfaction scores using validated questionnaires	6 months