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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2009
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 CONDITION: Cataract surgery / intraocular lens / accommodation ; Eye Diseases ; Senile cataract PRIMARY OUTCOME: 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: 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. INCLUSION CRITERIA: 1. Male and female patients aged 18 years and above. 2. Bilateral age related cataracts and otherwise healthy eyes.
Epistemonikos ID: e48dc6eb0421ec8c7776e4a90fd8a0ee30d650a2
First added on: Aug 22, 2024