NCT05376917

Quality of Life Evaluation After Cataract Surgery Using 4 Types of Intraocular Lens Implant Combinations

Quality of Life and Uncorrected Binocular Visual Acuity (UBVA) Evaluation in Patients Undergoing Cataract Surgery Using 4 Different Types of Lens Implant Combinations: a Multicenter, Prospective, Comparative and Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is multicenter, prospective, comparative and randomized study focusing on the evolution of the quality of Life and Uncorrected Binocular Visual Acuity (UBVA) evaluation at 3 months after cataract surgery in patients who underwent 4 different types of intraocular lens Implant (IOL) combinations.

Detailed description

Cataract, linked to the loss of transparency of the lens, is the leading cause of blindness in the world. It requires exclusively surgical treatment. Cataract surgery by ultrasonic phacoemulsification is the most common surgical procedure in France (800,000/year). The lens is removed and replaced with an artificial intraocular lens. There are different types of implants that can be used. The simplest is the monofocal implant which is implanted in such a way as to correct "only far or near vision". For near vision or vice versa, it is therefore necessary to wear corrective lenses after the operation. A technique that eliminates the need for distance and near correction is based on monovision. This is a presbyopia compensation technique that aims to induce a slight myopization of one eye for near vision (usually the dominated eye) the other eye being intended for distance vision (dominant eye). There is therefore a difference in correction and perception of the images. Depending on the fixed distance, one eye will see sharp, the other less clear, even blurry. This difference can lead to a reduction in the perception of relief. Other methods of compensating for presbyopia include the use of so-called multifocal or extended depth of field implants; they are also not devoid of sometimes annoying side effects (in particular possible halos around light sources at night) which can lead in rare cases to the removal of the intraocular lens. However, patient requirements in terms of comfort of vision and independence from glasses are increasingly high and patients themselves are increasingly informed of the existence of multifocal implants. The choice of the intraocular implant to use is therefore a real challenge, especially since patients are often still active on a professional level. Moreover, there is a lack of scientific consensus related to the choice of implants, during a surgical treatment of cataract lenses by phakoexeresis, for otherwise healthy eyes and in a subject wishing to no longer wear glasses postoperatively. . Different studies have emerged comparing the bilateral implantation of different types of multifocal implants with each other, but there is little work concerning mixed batches of "mix - match" implants.

Conditions

• Cataract
• Intraocular Lens Implant

Interventions

Type	Name	Description
DEVICE	Zeiss CT Asphina / Zeiss CT Asphina	Monovision with refractive target of -1.50D on the dominated eye
DEVICE	Zeiss AT Lara/ Zeiss AT Lisa Tri	Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)
DEVICE	Zeiss CT Asphina/ Zeiss AT Lara	Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)
DEVICE	Zeiss AT Lara / Zeiss AT Lara	Micromonovision with refractive target of -0.75D on the non-dominant eye

Timeline

• Start date: 2023-01-30
• Primary completion: 2025-05-21
• Completion: 2025-05-21
• First posted: 2022-05-17
• Last updated: 2025-05-28

Locations

2 sites across 1 country: France