An interventional study of Zeiss CT Asphina / Zeiss CT Asphina and Zeiss AT Lara/ Zeiss AT Lisa Tri in Cataract and Intraocular Lens Implant, sponsored by Centre Hospitalier Régional Metz-Thionville. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Centre Hospitalier Régional Metz-Thionville · Not applicable, Interventional, and Other
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 200 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 118 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Monovision with refractive target of -1.50 Diopters (D) on the dominated eye
Device: Zeiss CT Asphina / Zeiss CT Asphina
Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)
Device: Zeiss AT Lara/ Zeiss AT Lisa Tri
Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)
Device: Zeiss CT Asphina/ Zeiss AT Lara
Micro-monovision with refractive target of -0.75 Diopters (D) on the non-dominant eye
Device: Zeiss AT Lara / Zeiss AT Lara
Monovision with refractive target of -1.50D on the dominated eye
Zeiss AT Lara (dominant eye) / Zeiss AT Lisa Tri (non-dominant eye)
Zeiss CT Asphina/ Zeiss AT Lara (non-dominant eye)
Micromonovision with refractive target of -0.75D on the non-dominant eye
National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score before cataract surgery
Quality of life score is obtained using the National Eye Institute Visual Functioning Questionnaire - 25 (NEI VQF-25) questionnaire score and measured before intervention. NEI VFQ-25 questionnaire measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The Visual Function Questionnaire (VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points (100 is the best score), respectively.
Time frame: Few days before surgery
National Eye Institute Visual Functioning Questionnaire - 25 (NEI VFQ-25) questionnaire score 3 months after surgery
Quality of life score is obtained using the National Eye Institute Visual Functioning Questionnaire - 25 (NEI VQF-25) questionnaire score and measured 3 months after intervention. NEI VFQ-25 questionnaire measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. The Visual Function Questionnaire-25 (VFQ-25) consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points (100 is the best score), respectively.
Time frame: 3 months after surgery
Uncorrected binocular visual acuity for far vision measured before intervention
Uncorrected binocular visual acuity for distance vision is measured before intervention using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.
Time frame: Few days before surgery
Uncorrected binocular visual acuity for intermediate vision measured before intervention
Uncorrected binocular visual acuity is measured before intervention using Parinaud scale for intermediate vision. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).
Time frame: Few days before surgery
Uncorrected binocular visual acuity for near vision measured before intervention
Uncorrected binocular visual acuity is measured before intervention using Parinaud scale for near vision. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).
Time frame: Few days before surgery
Uncorrected binocular visual acuity for far vision measured 4 days postoperatively
Uncorrected binocular visual acuity for far vision is measured 4 days postoperatively using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.
Time frame: 4 days after surgery
Uncorrected binocular visual acuity for intermediate vision measured 4 days postoperatively
Uncorrected binocular visual acuity for intermediate vision is measured 4 days postoperatively using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).
Time frame: 4 days after surgery
Uncorrected binocular visual acuity for far vision measured 1 month postoperatively
Uncorrected binocular visual acuity is measured 1 month after surgery using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.
Time frame: 1 month after surgery
Uncorrected binocular visual acuity for intermediate vision measured 1 month postoperatively
Uncorrected binocular visual acuity is measured 1 month after surgery using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).
Time frame: 1 month after surgery
Uncorrected binocular visual acuity for near vision measured 1 month postoperatively
Uncorrected binocular visual acuity is measured 1 month after surgery using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).
Time frame: 1 month after surgery
Uncorrected binocular visual acuity for far vision measured 3 months postoperatively
Uncorrected binocular visual acuity is measured 3 months after surgery using Monoyer scale for far vision, scores ranging from 1 to 10, higher scores mean a better outcome; score 10 is the best.
Time frame: 3 months after surgery
Uncorrected binocular visual acuity for intermediate vision measured 3 months postoperatively
Uncorrected binocular visual acuity for intermediate vision is measured 3 months after surgery using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).
Time frame: 3 months after surgery
Uncorrected binocular visual acuity for near vision measured 3 months postoperatively
Uncorrected binocular visual acuity for near vision is measured 3 months after surgery using Parinaud scale. The Parinaud scale ranges from Parinaud 14 (P 14) (lowest score) to Parinaud 1.5 (P 1.5) (best score).
Time frame: 3 months after surgery
Sunglasses wear frequency 3 months after surgery for far and near visions
Frequency of wearing sunglasses in patients undergoing IOL implant surgery : permanently (yes/no) or occasionally (yes/no) for far and near visions
Time frame: 3 months after surgery
Eye tonicity before surgery
Eye pressure measurement millimeters of mercury (mmHg) before intervention
Time frame: Few days before surgery
Eye tonicity 4 days postoperatively
Eye pressure measurement millimeters of mercury (mmHg) 4 days postoperatively
Time frame: 4 days after surgery
Eye tonicity 1 month postoperatively
Eye pressure measurement millimeters of mercury (mmHg) 1 month postoperatively
Time frame: 1 month after surgery
Eye tonicity 3 months postoperatively
Eye pressure measurement millimeters of mercury (mmHg) 3 months postoperatively
Time frame: 3 months after surgery
Slit lamp and Macular Optical coherence tomography (OCT) examination before surgery
Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No) Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)
Time frame: Few days before surgery
Slit lamp and Macular OCT examination 4 days postoperatively
Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No) Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)
Time frame: 4 days after surgery
Slit lamp and Macular OCT examination 1 month postoperatively
Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No); Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)
Time frame: 1 month after surgery
Slit lamp and Macular OCT examination 3 months postoperatively
Presence of postoperative complications: Persistent lens mass (Yes/No); Tyndall effect (Yes/No); Hyphema (Yes/No); Irian hernia (Yes/No); Endophthalmitis (Yes/No); Implant dislocation (Yes/No)
Time frame: 3 months after surgery
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Centre Hospitalier Régional Metz-Thionville