Retrospective/prospective Clinical Study of AcrySof (Registered Trademark) IQ ReSTOR (Registered Trademark) +2.5 D Multifocal Toric Intraocular Lenses, which will collect information about the safety and effectiveness (how the lens works) from participants who have had cataract surgery and been implanted with these intraocular lenses

The primary objective of the study is to characterize the safety (adverse events) and effectiveness (residual cylinder and visual acuity) of the ACRYSOF IQ ReSTOR +2.5 D Multifocal Toric IOL in primary eyes of subjects at least 3 months and no more than 14 months after IOL implantation. The primary eye is defined as the eye of a subject that qualifies with the most recent implantation of the study lens (ACRYSOF IQ ReSTOR +2.5 D Multifocal Toric IOL Models SV25T2- SV25T5).

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12614000798662

Enrollment

Registered

2014-07-28

Start date

2014-07-21

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a retrospective and prospective clinical study comprised of a retrospective chart review for preoperative, surgical and early postoperative data and a prospective postoperative visit conducted at least 3 months but not more than 14 months after IOL implantation. The study is unmasked with no control group, no randomization and will include approximately 4 sites. The primary objective of the study is to characterize the safety (adverse events) and effectiveness (residual cylinder and visual acuity) of the AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL in primary eyes of subjects at least 3 months and no more than 14 months after IOL implantation. The primary eye is defined as the eye of a subject that qualifies with the most recent implantation of the study lens (AcrySof IQ ReSTOR +2.5 D Multifocal Toric IOL Models SV25T2-SV25T5)

Interventions

A: The AcrySof IQ ReSTOR +2.5 D Multifocal Toric Intraocular Lens is implanted during cataract surgery to replace the cataractous lens B: Once as the AcrySof IQ ReSTOR +2.5 D Multifocal Toric Intraocular Lens stays in the eye for life of the patient

Eligibility

Sex/Gender

All

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

must sign an informed consent and be willing to come in for a visit at least 3 mths and not more than 14 mths after IOL implantation with the AcrySof IQ ReSTOR +2.5D multifocal toric IOL;must be implanted with the corrected lens based on preoperative corneal astigmatism; must complete a visit within 10 days after IOL implantation; successful capsular bag implantation with no surgical complications;

Exclusion criteria

IOL implanted prior to the AcrySof (Registered Trademark) IQ ReSTOR (Registered Trademark) +2.5 D Multifocal Toric IOL; Ocular or intraocular infection or inflammation at the same time of the preoperative visit; Any ocular surgery (eg. LASIK, corneal transplant, limbal relaxing incision, etc.) or intraocular laser procedure (SLT, ALT, etc.) at or prior to the surgical visit; Any conditions affecting the cornea (eg. Corneal dystrophy, severe dry eye) at the preoperative visit; Retinal conditions (e.g degenerative retinal conditions, history of retinal detachment, diabetic retinopathy) at the preoperative visit; Known history of type 1 or 2 diabetes for more than 5 years; Any ocular or systemic co-morbidity at the preoperative visit; Pregnant at the preoperative visit or at the time of the Post-operative visit ;preoperative corneal astigmatism <0.5D; participation in another clinical study at the preoperative visit or at the time of the final study visit

Outcome results