Evaluation of the "Bag-in-the-Lens" intraocular lens
| ISRCTN | ISRCTN81435288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81435288 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of Ophthalmology
St. Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Prospective single-centre unmasked randomised controlled trial with intraindividual comparison. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/02/2008 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 26 patients (52 eyes) |
| 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
- England
- United Kingdom
Study participating centre
Department of Ophthalmology
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guy's & St. Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Karen Ignatian
Research Governance Specialist
Research & Development Department
3rd Floor Conybeare House
Guy's Hospital
St. Thomas Street
London
SE1 9RT
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Hospital/treatment centre
Guy's and St. Thomas' NHS Foundation Trust (UK) - Cataract and IOL Research Fund
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/07/2016: No publications found, verifying study status with principal investigator.
