Post-Market Follow-up Clinical Trial to Investigate Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF In Comparison With a Multifocal (TECNIS Symfony® Extended Range of Vision IOL) and a Monofocal (AcrySof® IQ Monofocal IOL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- DCIVA in first implanted eyes
研究概览
简要总结
The objectives of the Post-Market Follow-up (PMCF) clinical investigation are to determine the safety and performance of a hydrophobic trifocal intraocular lens POD L GF in comparison with two comparator lenses: another multifocal intraocular lens (Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL); and a monofocal intraocular lens (Alcon AcrySof® IQ Monofocal IOL) through one year of post-operative assessments.
详细描述
This is a prospective, multicenter, randomized, active controlled comparative binocular Post Market Follow-up (PMCF) clinical study to demonstrate safety and efficacy between the trifocal intraocular lens POD L GF and the Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL and the Alcon AcrySof® IQ Monofocal IOL.
Patients who are scheduled to undergo cataract extraction in one or both eyes and posterior chamber intraocular lens implants may be screened for eligibility in the study and, if eligible, complete a pre-operative screening visit. Both eyes of subjects who are eligible to receive the POD L GF IOL or the Johnson & Johnson TECNIS Symfony® Extended Range of Vision IOL must be eligible to receive bilateral multifocal IOL implants. Both eyes of subjects who are eligible to receive the Alcon AcrySof® IQ Monofocal IOL must be eligible to receive bilateral monofocal IOL implants.
At the time of the first eye surgery, the subjects to be implanted with either the POD L GF (test) IOL or the Johnson & Johnson TECNIS Symfony® Extended Range of Vision (comparator) IOL will be randomized to receive either the test or comparator IOL in a 1:1 ratio. In addition, 50 subjects will be implanted with the Alcon AcrySof® IQ Monofocal IOL. All subjects will undergo bilateral IOL implantation and will receive the same brand of lenses in each eye. Second eye implantations will be delayed until 1 to 30 days after the first eye implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults ages 45 or older on the day of screening who have cataract(s) in one or both eyes
- •Capability to understand and sign an Ethics Committee (EC) approved informed consent form and privacy authorization
- •Corrected visual acuity projected by potential acuity meter (PAM) testing or other potential visual acuity test procedure to be better than 20/32 after intraocular lens implantation
- •Clear intraocular media other than cataract
- •Calculated IOL power is within the range of the study IOLs
- •Dilated pupil size large enough to visualize IOL axis markings postoperatively
- •Willing and able to conform to the study requirements
排除标准
- •Subjects with diagnosed degenerative visual disoerders (e.g., macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse
- •Subjects with age-related macular degeneration (AMD) suspicious eyes as determined by optical coherence tomography (OCT) examination
- •Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema
- •Greater than 1 diopter of pre-operative corneal astigmatism or any irregular astigmatism
- •Previous intraocular or corneal surgery
- •Traumatic cataract
- •History or presence of macular edema
- •Pregnant,lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study
- •Concurrent or previous (within 30 days) participation in another drug or device investigation
- •Instability of keratometry or biometry measurements
- •Ocular hypertension or glaucoma
- •Significant dry eye
- •Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgement (reason to be documented on eCRF)
结局指标
主要结局
DCIVA in first implanted eyes
时间窗: Day 120-180 both eyes
Photopic monocular logMAR intermediate visual acuity with distance correction (DCIVA) in first implanted eyes at Visit 4
DCNVA in first implanted eyes
时间窗: Day 120-180 both eyes
Photopic monocular logMAR near visual acuity with distance correction (DCNVA) in first implanted eyes at Visit 4
CDVA in first implanted eyes
时间窗: Day 120-180 both eyes
Photopic monocular logMAR corrected distance visual acuity (CDVA) in first implanted eyes at Visit 4
次要结局
- CDVA at Visits 3A, 3B, 4, and 5(Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5))
- UDVA at Visits 3A, 3B, 4, and 5(Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5))
- UNVA at Visits 3A, 3B, 4, and 5(Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5))
- Near Activity Visual Questionnaire (NAVQ) quality of vision at Visit 4(Day 120-180 both eyes)
- DCIVA at Visits 3A, 3B, 4, and 5(Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5))
- DCNVA at Visits 3A, 3B, 4, and 5(Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5))
- UIVA at Visits 3A, 3B, 4, and 5(Day 30-60 post first eye (3A), day 30-60 post second eye (3B), day 120-180 both eyes (4), day 330-420 both eyes (5))
- Quality of Vision Questionnaire (QoV) quality of vision at Visit 4(Day 120-180 both eyes)