RAJIVGANDHI UNIVERSITY OF HEALTH SCIENCES OF KARNATAKA BANGALORE, KARNATAKA ANNEXURE – II PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION DR.NIVEDITHA M N 1. Name of the Candidate D/O NIRVANI GOWDA M N and Address #137,MARUTI NILAYA, NEAR OXFORD ENGLISH SCHOOL, (in Block Letters) LIG 2nd STAGE, KUVEMPU NAGAR HASSAN-573201

2. Name of the Institution J.J.M. MEDICAL COLLEGE, DAVANAGERE. KARNATAKA.

3. Course of the Study and Subject M.S - OPHTHALMOLOGY

4. Date of Admission to Course 29-07-2013

5. Title of the Topic A CLINICAL STUDY OF PHACOEMULSIFICATION WITH MULTIFOCAL INTRAOCULAR LENS.

6. BRIEF RESUME OF THE INTENDED WORK

6.1 Need for the Study:

Currently, the goal of cataract surgery is to provide fast and complete visual rehabilitation without surgical complications with minimal postoperative refractive errors1. Phacoemulsification has become the preferred method of cataract extraction over the last 15yrs. The smaller incision of phacoemulsification is associated with little induced postoperative astigmatism and early stabilization of refraction2. Mono focal IOLs provide excellent distance vision, but patients are still dependent on spectacles for near and intermediate vision. This problem can be addressed by implanting a multifocal IOL3.

Several materials are used to compensate for the loss of accommodation from implantation of an intraocular lens (IOL), including multifocal IOLs, accommodating IOLs and monovision. Among these approaches, bilateral implantation of multifocal IOLs is the most popular. Multifocal IOLs generate different foci to address the visual limitation at near and intermediate distances that occurs with classic monofocal IOLs. Indeed, multifocal IOLs have been shown to provide good distance and near functional vision without the use of corrective lenses. However, some optical side effects have been reported, including decreased contrast sensitivity, glare disability and halos, which can significantly affect the patient’s visual performance and satisfaction. The aim of this study is to evaluate the benefits and disadvantages of multifocal IOLs1.

The principle of any multifocal design is to create multiple image points behind the lens. The goal of these lenses is to enable less reduction in visual acuity for a given amount of defocus by improving the depth of field. The multifocal IOL is a zonal progressive IOL with five concentric zones on the anterior surface. Zones 1, 3, and 5 are distance dominant zones, whereas zones 2 and 4 are near dominant. The lens has an aspherical component; thus, each zone repeats the entire refractive sequence corresponding to distance, intermediate, and near foci. This results in vision over a range of distances. The lens uses 100% of the incoming available light and is weighted for optimum light distribution. With typical pupil sizes, approximately one-half of the light is distributed for distance, one-third for near vision, and the remainder for intermediate vision. The lens uses continuous surface construction; consequently, no light is lost through diffraction, and no degradation of image quality occurs as a result of surface discontinuities4.

6.2 Review of Literature:

The earliest multifocal IOLs were introduced in the late 1980s.multifocal IOLs using diffractive, diffractive, and combinations of both optical principles have been developed5.

Tomofusa Yamauchi, Hitoshi Tabuchi, KosukeTakase, Hideharu Ohsugi, Zaigen Ohara, Yoshiaki Kiuchi did a study to compare the visual performance of multifocal intraocular lenses (IOLs) and mono focal IOLs made of the same material and the study concluded that the multifocal IOLs used in this study reduced spectacle dependency more so than monofocal IOLs and did not compromise the subjective visual function1. Marjan D. Nijkamp, Maria G.T. Dolders, John de Brabander, Bart van den borne, Fred Hendrikse, Rudy M.M.A. Nuijts conducted a randomized controlled trial to know the effectiveness of multi focal intraocular lenses to correct presbyopia after cataract surgery. Multifocal IOL’s showed significantly better uncorrected near VA than mono focal IOLs and an increase in quality ratings of unaided near vision patients with multifocal IOLs were more likely to “never” or “only now and then” wear spectacles for near and distance than patients with monofocal IOLs. Monofocal IOL patients showed fewer complaints from cataract symptoms, including halos and distorted vision6.

Yoshino M, Bissen-Miyajima H, Minami K did an assessment of whether visual outcomes with diffractive multifocal intraocular lenses vary with patients’ age. Eyes receiving a diffractive multifocal IOL after cataract extraction were divided into 5 age decades: 30s (30 to 39 years), 40s, 50s, 60s, and 70s and they concluded that corrected visual acuities and contrast sensitivity were worse in older patients than in younger patients. Visual acuities with the monofocal IOL were not associated with patient age7.

Sheppard AL, Shah S, Bhatt U, Bhogal G, Wolffsohn JS did a cohort study to assess clinical outcomes and subjective experience after bilateral implantation of a diffractive trifocal intraocular lens (IOL) and the study concluded that the trifocal IOL implanted binocularly produced good distance visual acuity and near and intermediate visual function. Patients were very satisfied with their uncorrected near vision8.

Fuxiang Zhang, Alan Sugar, Gordon Jacobsen, Melissa Collins did a prospective cohort study to evaluate and compare patient-reported visual function, spectacle independence, and quality of life before and after cataract surgery with bilateral diffractive multifocal or monofocal intraocular lens (IOL) implantation and they concluded that bilateral multifocal IOLs and conventional mono focal IOL pseudophakic mono vision significantly improved spectacle independence and visual quality-of-life measures9.

John F Blaylock, Zhaomin Si, Cheryl Vickers did a study to evaluate the visual acuity and determine the refraction in emmetropic pseudophakic eyes at different focal distances after implantation of multifocal intraocular lens (IOL)and they concluded that implantation of the multifocal IOL offered excellent visual acuity at distance and near distance and functional visual acuity in the intermediate range. For patients who need excellent vision at intermediate range, leaving 1 eye with distance myopia or hyperopia to compensate for intermediate vision may provide consistent good binocular vision over the full range in cases of bilateral implantation10.

Charles claoue did a prospective study comprising patients scheduled to have standard phacoemulsification surgery with IOL implantation.17 patients had bilateral implantation of the multifocal IOL ,and 5 patients had implantation of the accommodating IOL and they concluded that greater proportion of multifocal IOL recipients than accommodating IOL recipients achieved functional near vision acuity. Only 1 patient with a multifocal IOL required corrective spectacles at the last visit3.

Jorge L. Alió, Ana B. Plaza-Puche, David P. Piñero, Francisco Amparo, Ramón Jiménez, Jose L. Rodríguez-Prats et al done a prospective cohort study to evaluate the reading performance, changes in quality of life, and optical performance after cataract surgery with multifocal diffractive intraocular lens (IOL) implantation and they concluded that implantation of the multifocal diffractive IOL significantly improved reading performance, which had a positive effect on the patient’s quality of life postoperatively11.

Tanja M. Rabsilber, Paulius Rudalevicius, Vytautas Jasinskas, Mike P. Holzer, Gerd U. Auffarth, did a clinical prospective nonrandomized unmasked study to clinically evaluate different near additions (adds) (+3.00 diopters [D] and +4.00 D) of the refractive multifocal intraocular lens (IOL) and they concluded that compared with the +4.00 D add, the +3.00 D near add gave better intermediate results in the defocus curve without compromising distance or near visual acuity12.

6.3 Aims and Objective of the study:

. To evaluate the postoperative visual outcome (distance vision and near vision) of phacoemulsification with multifocal IOL.

. To evaluate the complications of phacoemulsification with multifocal IOL.

7. MATERIALS AND METHODS

7.1 Source of Data :

Around 25patients having significant cataract attending the Department of Ophthalmology at Chigateri General Hospital and Bapuji Hospital attached to JJM Medical college, Davanagere from November, 2013 to September, 2015will be included in this study.

7.2 Method of Collection of Data:

This is a prospective interventional study. Around 25 Patients with cataract would be enrolled into study after taking informed and written consent. After detailed history taking, every patient will undergo the following preoperative ophthalmologic examination which includes distance visual acuity by snellen’s chart and near visual acuity, radius of curvature (k1 and k2) by keratometry, axial length by A scan ultrasound, refractive status, pupil size in mesopic conditions and in dim light, contrast sensitivity, anterior segment evaluation with slit lamp, tonometry, indirect fundoscopy and lens opacity classification. Patient will then undergo phacoemulsification with multifocal IOLs and postoperatively will be evaluated for distance and near visual acuity, contrast sensitivity, glare and halos on 1st day, 4th week and 6th week.

Inclusion Criteria:

. Subjects having significant cataract.

. 25 years of age or older.

. Patient desiring cataract extraction with multifocal IOLs

. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures.

. Naturally dilated pupil size (in dim light) > 3.5 mm (with no dilation medications) for both eyes. . Visual potential of 20/30 or better in each eye after lens removal and IOL implantation.

Exclusion Criteria :

. Ocular diseases that affected the visual function like proliferative diabetic retinopathy, retinal detachment, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.

. Keratometric astigmatism exceeding 2.0 diopters.

. Use of any systemic or topical drug known to interfere with visual performance.

. Any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis.

. Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.

. Other ocular surgery at the time of the cataract extraction.

. Use of systemic or ocular medications that may affect visual outcomes and pupil size.

. Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome).

. Pupil abnormalities (non-reactive, tonic pupils or abnormally shaped pupils)

. Requiring an intraocular lens power <15.0 or >26.0D

Sample Size:

25 cases with CATARACT.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly. Yes  The investigations are a part of routine clinical practice checkup and the cataract surgery will be done with the consent of the patient within normal surgery protocol.

7.4 Has ethical clearance been obtained from your institution in case of 7.3? Yes

8 List of References:

1) Yamauchi T, Tabuchi H, Takase K, Ohsugi H, Ohara Z, et al. (2013) Comparison of Visual Performance of Multifocal Intraocular Lenses with Same Material Monofocal Intraocular Lenses. PLoS ONE 8(6): e68236. doi:10.1371/journal.pone.0068236

2) Jack J Kanski, Brad Bowling. Clinical ophthalmology: a systemic approach, 7th edition, p: 281.

3) Charles Claoue´. Functional vision after cataract removal with multifocal and accommodating intraocular lens implantation Prospective comparative evaluation of Array multifocal and 1CU accommodating lenses. J Cataract Refract Surg2004; 30:2088–2091.

4) I. Howard Fine, M.D.Richard S. Hoffman, M.D.Mark Packer, M.D. Clear lens extraction with multifocal lens implantation. JIntOphthalmolClin. 2001;41(2):113- 21.

5) Niels E. de Vries, Rudy M.M.A. Nuijts. Multifocal intraocular lenses in cataract surgery: Literature review of benefits and side effects. J Cataract Refract Surg 2013; 39:268–278.

6) Marjan D. Nijkamp, Maria G.T. Dolders, John de Brabander, Bart van den Borne, Fred Hendrikse, Rudy M.M.A. Nuijts. Effectiveness of multifocal intraocular lenses to correct presbyopia after cataract surgery.J ophthalmology 2004;111,(10) : 1832-1839.e2

7) Yoshino M, Bissen-Miyajima H, Minami K. Assessment of whether visual outcomes with diffractive multifocal intraocular lenses vary with patient age. J Cataract Refract Surg. 2013 Oct;39(10):1502-6.

8) Sheppard AL, Shah S, Bhatt U, Bhogal G, WolffsohnJS.Visual outcomes and subjective experience after bilateral implantation of a new diffractive trifocal intraocular lens.J Cataract Refract Surg. 2013 Mar;39(3):343-9.

9) Fuxiang Zhang, Alan Sugar, Gordon Jacobsen, Melissa Collins. Visual function and spectacle independence after cataract surgery: Bilateral diffractive multifocal intraocular lenses versus monovision pseudophakia. Journal of Cataract 2011& Refractive Surgery; 37(5):853-858.

10) John F. Blaylock, Zhaomin Si, Cheryl Vickers. Visual and refractive status at different focal distances after implantation of the ReSTOR multifocal intraocular lens. Journal of Cataract & Refractive Surgery 2006; 32(9):1464-1473.

11) Jorge L. Alió, Ana B. Plaza-Puche, David.P. Piñero, Francisco Amparo, Ramón Jiménez, Jose L. Rodríguez-Pratset al. Optical analysis, reading performance, and quality-of-life evaluation after implantation of a diffractive multifocal intraocular lens.Journal of Cataract & Refractive Surgery 2011; 37(1): 27-37.

12) Tanja M. Rabsilber, Paulius Rudalevicius, Vytautas Jasinskas, Mike P. Holzer, Gerd U. Auffarth. Influence of +3.00 D and +4.00 D near addition on functional outcomes of a refractive multifocal intraocular lens model. Journal of Cataract & Refractive Surgery 2013; 39(3):350-357. 9. Signature of Candidate

10. Remarks of the Guide Multifocal IOL’S addresses the problem of both correction of distance and near vision. This study is done to evaluate the visual outcome of phaco with multifocal IOL and to be submitted. 11. Name and Designation of Dr. S. MAHESHWARAPPA (in block letters) MS, DOMS PROFESSOR, 11.1 Guide DEPARTMENT OF OPHTHALMOLOGY J.J.M. MEDICAL COLLEGE, DAVANGERE – 577 004.

11.2 Signature

11.3 Co-Guide (if any)

11.4 Signature

Dr. RAVINDRANATH S.V. 11.5 Head of Department MS, DOMS PROFESSOR AND HEAD, DEPARTMENT OF OPHTHALMOLOGY J.J.M. MEDICAL COLLEGE, DAVANGERE – 577 004.

11.6 Signature

12. 12.1 Remarks of the Dr.MANJUNATH ALUR Chairman and Principal Principal and Professor of medicine, JJM MEDICAL COLLEGE Davangere-577004

12.2 Signature