Evaluation of the "Bag-in-the-Lens" intraocular lens

ISRCTN	ISRCTN81435288
DOI	https://doi.org/10.1186/ISRCTN81435288
Protocol serial number	N/A
Sponsor	Guy's & St. Thomas' NHS Foundation Trust (UK)
Funder	Guy's and St. Thomas' NHS Foundation Trust (UK) - Cataract and IOL Research Fund

Submission date: 09/11/2009
Registration date: 27/11/2009
Last edited: 18/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr David J Spalton
Scientific

Department of Ophthalmology
St. Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective single-centre unmasked randomised controlled trial with intraindividual comparison.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluation of the Morcher BioCom Fold Type 89A "Bag−in−the−Lens" intraocular lens: accommodative performance, near vision and posterior capsule opacification
Study objectives	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(s)	Approved by the St. Thomas' Hospital Research Ethics Committee in February 2008 (Ref: 08/H0802/12)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	26
Key inclusion criteria	1. Male and female patients aged 18 years and above. 2. Bilateral age related cataracts and otherwise healthy eyes.
Key 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
Date of first enrolment	01/02/2008
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Ophthalmology

London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/07/2016: No publications found, verifying study status with principal investigator.