The objectives of this study are to assess and compare bilateral uncorrected distance visual acuity and distance spectacle independence post bilateral implantation of AcrySof Toric IOLs and monofocal IOLs.
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Uncorrected Distance Visual Acuity
Spectacle Independence
Secondary outcome
Vision-related quality of life
Cost of Postoperative Spectacle Correction
Adverse Events & Rate of surgical re-intervention
Background summary
Developments in cataract surgery are rapidly evolving, including the continuing
development of intraocular lenses (IOLs) to correct for optical aberrations
including astigmatism.
The objectives of this study are to assess and compare bilateral uncorrected
distance visual acuity and distance spectacle independence post bilateral
implantation of AcrySof Toric IOLs and monofocal IOLs. Secondary outcomes will
include cost of eyeglass purchased and patient vision-related quality of life.
Study objective
The objectives of this study are to assess and compare bilateral uncorrected
distance visual acuity and distance spectacle independence post bilateral
implantation of AcrySof Toric IOLs and monofocal IOLs.
Study design
This study is a postmarket, subject and observer masked, comparative trial
involving the treatment of astigmatism at the time of cataract surgery and
assessment of postoperative resource utilization. Subjects will be assessed 1
day after each operative visit and 1 month, 3 months and 6 months following the
2nd eye surgery. Postoperative clinical evaluations will include manifest
refraction, visual acuity, keratometry, tonometry, and a patient reported
outcome questionnaire.
At the 6-month visit patients will be asked to provide a copy of the spectacles
purchase receipt which should be kept as a source document.
Intervention
There are 2 groups of subjects:
Group 1 will receive AcrySof Toric IOL, group 2 monofocal lens implantation.
Study burden and risks
Risks:
This study can have the following complications associated with IOL
implantation during surgery:
Complications such as pain, redness or ocular itching and light sensitivity can
occur. There is a very small risk for your visual acuity to decrease because of
surgery, for example in case of bleeding, infection (endophtalmitis),
inflammation, retinal detachment, raise of intra-ocular pressure (i.e.
glaucoma) or corneal opacification. The Intra-ocular lens can also change after
the surgery.
Further complications associated with the implantation of intraocular lenses
may include but are not limited to the following: corneal endothelial damage,
acute cornea decomposition, vitritis, cystoid macular edema, corneal edema,
papillary block, cyclitic membrane, iris prolaps, hypopyon, infection,
transient of persistent glaucoma and secondary surgical intervention.
Secundary surgical interventions include, but are not limited to: lens
repositioning, lens replacement, vitreous aspirations or iridectomy for
papillary block, wound leak repair, and retinal detachment repair.
Questionnaires:
Furthermore some questionnaires need to be filled out by the subjects.
3 x vision-related quality of life questionnaires.
An additional questionnaires that will assess e.g. costs of spectacles
purchased.
Pentagon Park, Boundary Way, Hemel Hempstead
Hertfordshire HP2 7UD
United Kingdom
Pentagon Park, Boundary Way, Hemel Hempstead
Hertfordshire HP2 7UD
United Kingdom
Listed location countries
Age
Inclusion criteria
Ocular criteria must be met in both eyes:
are >= 21 years of age;
have bilateral, age related, cataracts;
have planned cataract removal via phacoemulsification with implantation of an IOL;
are available to undergo second eye surgery within 6 weeks of the first eye surgery;
are in good ocular health, with the exception of cataracts;
-As indicated in the *Precautions* section of the AcrySof Toric and monofocal package inserts, potential subjects should exhibit a favorable preoperative benefit/risk ratio for lens implantation, in the surgeons medical judgment, when one or more of the following conditions exists: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, irregular corneal astigmatism, color vision deficiencies, corneal endothelial disease, abnormal cornea, macular or retinal degeneration or chronic drug miosis,
qualify for bilateral AcrySof Toric IOLs on the AcrySof Toric Calculator;
have regular corneal astigmatism;
are able to obtain pupil dilation >= 5.0 mm.
Exclusion criteria
If any of the following exclusion criteria are applicable to either eye, the subject should not be enrolled in the study:
previous corneal surgery and/or reshaping;
abnormality, disease and/or conditions of the cornea (i.e. keratoconus, corneal dystrophy, keratitis, corneal scar, etc.), which would clinically contra-indicate the implantation of a toric intraocular lens;
planned multiple procedures during cataract/IOL implantation surgery;
planned limbal relaxing incision (LRI), Excimer laser treatment or similar procedure prior to or during the course of the study;;pregnant, lactating or planning pregnancy during course of study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31888.068.10 |