Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of the Morcher BioCom Fold Type 89A "Bag−in−the−Lens" intraocular lens: accommodative performance, near vision and posterior capsule opacification
Acronym
Study hypothesis
The aim of this study is to evaluate the accommodative and near visual performance of the BIL in comparison to a conventional in-the-bag IOL.
Ethics approval
Approved by the St. Thomas' Hospital Research Ethics Committee in February 2008 (Ref: 08/H0802/12)
Study design
Prospective single-centre unmasked randomised controlled trial with intraindividual comparison.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Cataract surgery / intraocular lens / accommodation
Intervention
Phacoemulsification cataract extraction and intraocular lens (IOL) implantation (one of each IOL type randomised to either eye in participants):
1. Investigational IOL: the "Bag-in-the-Lens" IOL (Morcher BioComFold Type 89A)
2. Control IOL: the Alcon AcrySof SA60AT
Follow-up: 2 years
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Objective IOL movement with accommodative effort (µm):
Axial IOL movement measured 3 months postoperatively with partial coherence interferometry (Zeiss AC Master) under three accommodative conditions:
1. physiological near visual stimulation
2. pilocarpine
3. cyclopentolate
Secondary outcome measures
1. Objective amplitude of accommodation (D) measured 3 months postoperatively with aberrometry (Tracey Visual Function Analyzer)
2. Subjective accommodative amplitude (D) measured at 1 and 3 months with the push-up test (RAF rule accommodometer)
3. Defocus curves (logMAR) measured at 1 and 3 months as logMAR visual acuity under defocus conditions between +3D and -3D in 0.5D steps
4. Visual performance (logMAR), measured at 1, 3, 6, 12 and 24 months under the following conditions:
4.1. Distance visual acuity without spectacle correction
4.2. Distance visual acuity with spectacle correction
4.3. Near visual acuity without spectacle correction
4.4. Near visual acuity with distance spectacle correction
4.5. Near visual acuity with near spectacle correction
5. Posterior capsule opacification (percentage area PCO) calculated at 1, 3, 6, 12 and 24 months from digital retroillumination images using POCO software.
Overall trial start date
01/02/2008
Overall trial end date
01/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female patients aged 18 years and above.
2. Bilateral age related cataracts and otherwise healthy eyes.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
26 patients (52 eyes)
Participant exclusion criteria
1. Corneal astigmatism greater than 1.50D (determined by IOL Master keratometry)
2. Pupillary dilation less than 6.0mm
3. Coexisting ocular pathology, including:
3.1. amblyopia
3.2. corneal disease
3.3. inflammatory eye disease
3.4. glaucoma
3.5. diabetic retinopathy
3.6. age related macular degeneration
3.7. previous intraocular surgery
Recruitment start date
01/02/2008
Recruitment end date
01/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Ophthalmology
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's & St. Thomas' NHS Foundation Trust (UK)
Sponsor details
c/o Karen Ignatian
Research Governance Specialist
Research & Development Department
3rd Floor Conybeare House
Guy's Hospital
St. Thomas Street
London
SE1 9RT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK) - Cataract and IOL Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary