Cataracts Eye Diseases Other cataract
Conditions
Interventions
We plan to randomise patients who have no significant ocular copathology, and are undergoing bilateral sequential cataract surgery or bilateral sequential refractive lens exchanged to either bilateral
Sponsors
Moorfields Eye Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients undergoing sequential bilateral cataract surgery or refractive lens exchange 2. Patients that want to be spectacle independent 3. Male or female, aged 21 years and above
Exclusion criteria
Exclusion criteria: 1. Any significant ocular co-morbidity (amblyopia, age-related macular degeneration [ARMD], glaucoma, etc) precluding post-operative visual acuity (VA) of 20/30 or better or poor zonular/capsular stability (e.g. after trauma/severe pseudoxanthoma elasticum [PXE]) 2. Corneal astigmatism more than 1.50 D on IOLMaster keratometry. Corneal astigmatism between 1.00 - 1.50 D will be reduced using standardised limbal relaxing incisions (LRI). 3. IOLMaster biometry not possible 4. IOL power less than 10D or greater than 30D 5. Professional night drivers, pilots, and other occupations for which induced dysphotopsia may be career threatening 6. Patients with severe psychiatric disorders 7. Vulnerable groups 8. Poor mobility 9. Poor comprehension of written English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence of dysphotopsia symptoms (absent, mild, moderate, severe). Dysphotopsia (glare/haloes/visual disturbances) will be assessed with a questionnaire. Primary and secondary outcomes to be measured 4 - 6 months post-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Autorefraction and aberrometry and pupil size measurement using the Tracey aberrometer 2. Manifest subjective refraction and spectacle corrected monocular visual acuity measurement 3. Composite scoring of unaided visual acuity; distance and near monocular photopic. Binocular photopic distance, intermediate (50 - 60 - 70 cm) and near (40 cm) visual acuity. Binocular mesopic intermediate (70 cm), distance and near (using neutral density filters NoirU23). The composite scoring system is to be developed during the trial. Visual acuities will be measured using the New ETDRS logarithmic acuity card (Precision Vision). 4. Maximum binocular reading speed at patient preferred distance (IReST) 5. Binocular Near Reading speed 6. Binocular Contrast sensitivity - Pelli-Robson under photopic/mesopic conditions 7. Forward light scatter (C-quant) 8. Spectacle dependence questionnaire 9. Visual satisfaction questionnaire 10. Quality-of-life questionnaire (QIRC score) 11. Visual disability questionnaire - Catquest-9SF patient outcome questionnaire 12. Intra and postoperative complications 13. Slit lamp findings (dilated pupil): IOL centration 14. Adverse event recording (email and CRF) Primary and secondary outcomes to be measured 4 - 6 months post-operatively. | — |
Countries
United Kingdom
Outcome results
None listed