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

Evaluation of the Morcher BioCom Fold Type 89A "Bag-in-the-Lens" intraocular lens: accommodative performance, near vision and posterior capsule opacification

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81435288

Enrollment

Registered

2009-11-27

Start date

2008-02-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract surgery / intraocular lens / accommodation Eye Diseases Senile cataract

Interventions

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 (Morc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 18 years and above. 2. Bilateral age related cataracts and otherwise healthy eyes.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026