Distance And Intermediate Visual Acuity After Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared To Standard Monofocal Intraocular Lens
Phase: NA
Conditions: Lenses, Intraocular
Sponsor: Kasr El Aini Hospital

 
 
 
Distance And Intermediate Visual 
Acuity After Phacoemulsification 
Using A New Generation 
Monofocal Intraocular Lens 
Compared To Standard Monofocal 
Intraocular Lens 
NCT05430295 
Date:2-9-2022 
 

                                                                                                           
 
Research Template 
1 
 Final Version: April 2019
 
Faculty of Medicine, Cairo University Postgraduate 
Research Protocol Template 
 
1. Study 
 
a- Proposed Study Title: Distance And Intermediate Visual Acuity After 
Phacoemulsification Using A New Generation Monofocal Intraocular Lens Compared 
To Standard Monofocal Intraocular Lens .  
b- Degree :   Masters of ophthalmology. 
c- Date of Registration of MSc or MD: October 2019. 
 
3. Scientific committee approval  
(Was it scientifically approved by the department?) Yes 
 
            Date of approval:  
 
4. Background and Rationale:   
Cataract surgery is the most commonly performed surgery of the eye and 
monofocal intraocular lenses are the most widely used intraocular lenses. With the aspheric 
technology using the aspheric intraocular lenses like TECNIS 1-piece (Johnson & Johnson 
Vision, Santa Ana, CA, USA) can provide negative spherical aberration and results in 
better contrast sensitivity and visual quality (1), (2). 
 
Standard monofocal lenses only allow the patient’s vision to focus at one distance 
(i.e. distance or near), thus patients receiving monofocals often require glasses after surgery 
to improve their near and/or intermediate vision. 
Multifocal lenses are designed to split incident light into two or more points of 
focus, but these lenses are limited by the demands of minimizing optical aberration and 
balancing the focused and out -of -focus images (3)  
Multifocal IOLs are diffractive IOLS and are known for dysphotopsia (including 
glare and halos) that can negatively impact the quality of vision (4). 
 

                                                                                                           
 
Research Template 
2 
 Final Version: April 2019
In contrast to monofocal and multifocal IOLs, EDOF lenses e.g Symphony IOL 
(Johnson & Johnson Vision, Santa Ana, CA, USA ) are IOLs that provide an extended 
range of focus above a defined functional visual acuity threshold to provide useful distance 
and intermediate vision. 
Therefore, EDOF lenses should provide functional vision over a range of distances while 
ideally reducing the incidence of “bothersome” halos or glare which offer advantages to 
accommodate the patient’s lifestyle (5). 
 
The new Tecnis® Eyhance IOL (model ICB00, Johnson & Johnson Vision, Santa 
Ana, CA, USA), It is claimed to be an effective option for patients regarding better 
intermediate visual acuities relative to the standard monofocal intraocular lenses. It is a 
refractive modified monofocal lens with 0.50 D of additional power in its central 2-mm zone 
featuring a continuous change in power from the periphery to the center of the lens, creating 
a unique anterior surface that improves intermediate vision, maintains distance image quality 
comparable to aspheric monofocal IOLs, with similar profile of photic phenomenon and 
keeps on reducing spherical aberration close to zero (6). 
 
Considering the marginal price difference between the new Eyhance lens and the Tecnis 
monofocal aspheric lens, and the potential additional benefits of improving the intermediate 
distance vision while preserving the optical quality and minimal photic phenomena (7), we 
believe that proper study of the outcomes of using this lens could influence our choice of 
monofocal intraocular lenses in cataract patients. Hence, the objective of the study is to 
evaluate the distance, intermediate visual acuities, assess contrast sensitivity and photic 
phenomena, 
in 
patients 
undergoing 
cataract 
extraction 
with 
implantation 
of Tecnis® Eyhance (model ICB00, Johnson & Johnson Vision, Santa Ana, CA, USA) or 
Tecnis® 1-piece (model ZCB00, Johnson & Johnson Vision, Santa Ana, CA, USA) (8), (9). 
  
5. Objectives: 
 
1- Comparison of uncorrected and best corrected distance and intermediate vision in 
patients whom implanted with monofocal TECNIS Eyhance ((model ICB00) or 
TECNIS 1-piece (model ZCB00) IOLs after phacoemulsification. 

                                                                                                           
 
Research Template 
3 
 Final Version: April 2019
2- Evaluation of contrast sensitivity between the two patient groups. 
3- Evaluation of photic phenomena. 
6. Study Design:  
  
- 
Descriptive: - Survey (cross sectional)   
                   - Qualitative 
 
- 
Analytic: - Observational: - Case-control study 
                                        - Cross sectional analytic study 
                                        - Cohort (Longitudinal) study 
 
              - Experimental: - Randomized Clinical Trial                     Phase: 
                                       - Non-randomized clinical trial 
                                       - Animal study 
                                       - Cellular study 
 
- 
Others:   Please describe:  Prospective case series      
 
            
7. Study Methods 
 
- 
Population of study:  
Patients undergoing cataract surgery and implantation of monofocal intraocular lens 
Tecnis® Eyhance 1-piece  
Or Tecnis® 1-piece  
 

                                                                                                           
 
Research Template 
4 
 Final Version: April 2019
- 
Study location:  
Kasr Alainy & Eyecare center, Maadi, Cairo.(ETDRS chart, Pelli Robson illuminated 
chart, OPD scan being not available at Kasr Alainy hospitals). 
 
- 
Inclusion criteria: 
 Patients aged more than 50-75 years old undergoing cataract surgery. 
 Preoperative corneal astigmatism equal to or less than 0.75 D. 
 
 
- 
Exclusion criteria: 
 
Other ocular comorbidities such as glaucoma, corneal opacities, chronic or recurrent 
anterior uveitis, diabetic retinopathy, age -related macular degeneration. 
 
Previous ocular surgeries. 
 
Undergoing combined surgeries. 
 
Methodology in details: 
 
40 eyes of 20 patients will be included in this prospective study. The Tecnis® Eyhance IOL 
will be  implanted in 20 eyes of 10 patients (group 1), and 20 eyes of 10 patients will be 
implanted with Tecnis® 1-piece (group 2).  
 
 
Preoperative assessment: 
All selected patients will receive thorough explanation of the study design and aims, and an 
informed consent will be obtained from all patients. 
 Eyes before intervention will be subjected to: 
- Measurement of uncorrected and best-corrected distance visual acuity using ETDRS chart. 
- Slit lamp examination. 
- Measurement of intraocular pressure using applantation tonometer. 
- Dilated fundus examination using binocular indirect slit lamp biomicroscopy. 
- Specular microscopy . 

                                                                                                           
 
Research Template 
5 
 Final Version: April 2019
- Optical biometry using (IOLMaster 500; Carl Zeiss Meditec AG, Jena, Germany) and 
using online Barrett’s universal formula. With target refraction of 0 or +0.25 D in the 
Eyehance group  While in the Tecnis group the dominant eye will be aimed at 0 D and the 
non-dominat eye for -0.5 D. 
 
 
 
Surgical intervention: 
Surgery will be performed under topical anaesthesia using topical Benoxinate or local 
anaesthesia using peribulbar Lidocaine injection. 
 Speculum used to maintain lids open. 
 Clear corneal incision placed superotemporally using 2.2 mm keratome and 
paracenteses are placed using 15 superblade at 90 degrees to the main wound. 
  Followed by formation of anterior chamber using Ophthalmic Viscoelastic 
Device (hydroxypropyl methylcellulose). 
 Continuous curvilinear capsulorrhexis is created using straight sharp tipped 
Uttrata’s capsulorrhexis forceps aiming at 5 mm size. 
  Phacoemulsification of nucleus 
 Bimanual irrigation and aspiration of cortical material. 
 Injection of Ophthalmic Viscoelastic Device to form anterior chamber and 
inflate the capsular bag. 
 Implantation of Eyhance or Tecnis® 1-piece intraocular lens in capsular bag. 
 Irrigation and aspiration of Ophthalmic Viscoelastic Device. 
 Injection of intracameral moxifloxacin in the capsular bag and hydration of self-
sealing clear corneal incisions. 
 
Post-operative: 
All patients will receive a topical antibiotic (moxifloxacin) and steroids (Prednisolone 
acetate) eyedrops in a slow tapering course over 4 weeks. 
 
 
Follow up: 

                                                                                                           
 
Research Template 
6 
 Final Version: April 2019
All patients will be examined at day 1, 1 week and 1 month and 3 months  postoperative. 
 
At three months follow up all patients will be evaluated regarding: 
 Corrected and uncorrected distance (at 6 meters) and intermediate (at 66cm) vision 
both uniocular and binocular.  
 Photopic contrast sensitivity using Pelli Robson chart illuminated chart with 
controlled ambient illumination 
  Mean binocular defocus results will be measured and defocus curves of the two 
lenses will be created.  
 A questionnaire to evaluate the photic phenomena and spectacle independence will 
be explained and filled by the patients. 
Distance visual acuities will be examined by ETDRS chart and intermediate and near 
visual acuity by Jaeger chart at 66 cm and 33 cm respectively 
Measured values of the visual acuity will be expressed in decimal values and will be 
converted to logMAR values. 
 
- 
Intervention: 
 
- 
Diagnostic intervention (please describe):     
 
- 
Therapeutic intervention (please describe):  phacoemulsification, Eyhance IOL or 
TECNIS 1-piece IOL implantation.       
 
- 
No intervention  
 
Both diagnostic and therapeutic. 
 
- 
Does the research involve? 
          Human participants 

                                                                                                           
 
Research Template 
7 
 Final Version: April 2019
          Biological samples/Tissues 
          Identifiable private data/Information     
 
 
 
 
- 
Type of consent of study participants: 
 
          Written consent 
          Oral consent 
          No consent needed (Please justify) 
- 
Potential risks:  
(Please mention all risks involved even mild ones as pain, discomfort, chance of 
infection or psychological effects) 
 
1- Risks related to surgical intervention including corneal oedema, infection, retinal detachment, 
hemorrhage, IOL displacement, elevated intraocular pressure, optic atrophy, 
2- Risks related to intraocular lens including photic phenomena as halos and glare. 
 
 
- 
Confidentiality of data: will be maintained in a secure file with the investigators. 
 
      9- Study outcomes: 
- 
Primary outcomes (Most important measurable outcomes) 
Uncorrected and best-corrected distance, and intermediate visual acuity. 

                                                                                                           
 
Research Template 
8 
 Final Version: April 2019
- Secondary outcome parameters (other outcomes to be assessed) 
 
1) contrast sensitivity. 
2) Photic phenomena. 
3) Spectacle independence. 
 
         10- Sample size (number of study subjects included and justification including the clinical 
and statistical assumptions supporting sample size calculation) 
With a sample size of 18 (9/group), we will have a power of 95% to assess whether the mean 
logMAR For UIVA is significantly lower in the new monofocal IOL (~0.16 +/-0.06) compared to the 
standard monofocal IOL  with a mean logMAR for UIVA Of ~0.27 (0.06), using a 2 samples means 
test and a significance level of 0.05 
         11- Statistical analysis (Please describe your data analysis plan) 
Statistical plan 
Summary statistics will be done, categorical variables would be presented as frequency and percentages 
and numerical ones as mean (SD) or median (IQR) as appropriate. 
Comparison between the two groups will be done using the Students t test or the Wilcoxon rank sign 
test according to data normality. The Chi squared test will be used to compare categorical variables. 
P<0.05 will be considered significant. STATA 15.1 will be used for the analysis. 
 
         12- Source of funding: (Please include source of funding even if self funding) 
 
- 
Faculty of Medicine, Cairo University  

                                                                                                           
 
Research Template 
9 
 Final Version: April 2019
- 
Other sources: 
Please specify: self funding 
      13- Time plan:  
              
             - When to start? 
 Just after thesis registration  
 
              - When expected to finish? 
within 6 months or as soon as  number of participants has been reached. 
 
              - When to publish? As soon as results are available. 
  
      14- References:  
1. Jafarinasab, M. R., Feizi, S., Baghi, A. R., Ziaie, H., & Yaseri, M. (2010). Aspheric           versus 
spherical posterior chamber intraocular lenses. Journal of ophthalmic & vision research, 5(4), 
217. 
 
2. Unsal, U., & Sabur, H. (2020). Comparison of new monofocal innovative and standard 
monofocal intraocular lens after phacoemulsification. International Ophthalmology, 1-10. 
 
3. de Silva, S. R., Evans, J. R., Kirthi, V., Ziaei, M., & Leyland, M. (2016). Multifocal versus monofocal 
intraocular lenses after cataract extraction. Cochrane Database of Systematic Reviews, (12). 
 
4. Sheppard, A. L., Shah, S., Bhatt, U., Bhogal, G., & Wolffsohn, J. S. (2013). Visual outcomes and 
subjective experience after bilateral implantation of a new diffractive trifocal intraocular lens. Journal 
of Cataract & Refractive Surgery, 39(3), 343-349. 
 
5. Auffarth, G. U., Gerl, M., Tsai, L., Janakiraman, P., Jackson, B., Alarcon, A., & Dick, H. B. (2020). 
Clinical evaluation of a new monofocal intraocular lens with enhanced intermediate function in cataract 
patients. Journal of Cataract and Refractive Surgery. 
 
6. Tognetto, D., Cecchini, P., Giglio, R., & Turco, G. (2020). Surface profiles of new-generation IOLs 
with improved intermediate vision. Journal of Cataract & Refractive Surgery, 46(6), 902-906. 
 

                                                                                                           
 
Research Template 
10 
 Final Version: April 2019
7. Vega, F., Millán, M. S., Gil, M. A., & Garzón, N. (2020). Optical Performance of a Monofocal 
Intraocular Lens Designed to Extend Depth of Focus. Journal of Refractive Surgery, 36(9), 625-632. 
 
8. de Luis Eguileor, B., Martínez-Indart, L., Alday, N. M., Egüén, C. S., & Sánchez, C. C. (2020). 
Differences in intermediate vision: Monofocal intraocular lenses vs. monofocal extended depth of focus 
intraocular lenses. Archivos de la Sociedad Española de Oftalmología (English Edition), 95(11), 523-
527. 
 
9. Mencucci, R., Cennamo, M., Venturi, D., Vignapiano, R., & Favuzza, E. (2020). Visual outcome, 
optical quality, and patient satisfaction with a new monofocal IOL, enhanced for intermediate vision: 
preliminary results. Journal of Cataract & Refractive Surgery, 46(3), 378-387. 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

                                                                                                           
 
Research Template 
11 
 Final Version: April 2019