Condition category
Eye Diseases
Date applied
09/11/2009
Date assigned
27/11/2009
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr David J Spalton

ORCID ID

Contact details

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

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

http://www.guysandstthomas.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

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