RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1.NAME OF THE CANDIDATE : DR. KUMAR RAVI
ADDRESS: ROOM NO.5 ;5th BLOCK ; B. M. C. PG MEN’S HOSTEL, CHAMRAJPET, BANGALORE -560018
2. NAME OF THE INSTITUTION: BANGALORE MEDICAL COLLEGE AND RESEASCH INSTITUTE, BANGALORE -560002
3. COURSE OF STUDY AND SUBJECT: M.S. OPHTHALMOLOGY
4. ADMISSION TO THE COURSE: 3rd APRIL 2008
5. TITLE OF THE TOPIC: COMBINATION THERAPY OF INTRAVITREAL TRIAMCINOLONE FOLLOWED BY MACULAR LASER PHOTOCOAGULATION FOR DIFFUSE DIABETIC MACULAR EDEMA
6. BRIEF RESUME OF THE INTENDED STUDY: 6.1 NEED FOR THE STUDY:
Macular edema affects approximately 29% of diabetic patients and constitutes the primary cause of visual impairment in this population. The Early Treatment Diabetic Retinopathy Study9 reported that laser photocoagulation alleviated moderate visual loss in eyes with clinically significant macular edema by 50%.7
Intravitreal triamcinolone acetonide (IVTA) is known to significantly reduce central macular thickness and to improve best corrected acuity, in patients with diffuse macular edema especially with predominant cystoids macular spaces. IVTA is also known to improve visual acuity in patients with macular edema not responding to laser photocoagulation. However the chief limitation of IVTA is its short duration of action, which causes the recurrence of macular edema.
It is hypothesised that by performing both IVTA and laser photocoagulation, the two methods might act synergistically and thereby increase and prolong the beneficial effect of IVTA in reducing macular edema. Macular edema impairs laser energy uptake by retinal pigment epithelium due to the presence of fluid which can lead to suboptimal efficacy. Reduction of macular edema by IVTA first, may render better uptake of laser energy by RPE and achieve a better result.7
6.2 OBJECTIVES OF STUDY :
1. To find out the efficacy of combination therapy in diffuse diabetic macular edema.
a. To find out the visual outcome in treatment of diabetic macular edema with IVTA followed by macular laser.
b. To find out the reduction in central foveal thickness following IVTA and laser therapy.
6.3 REVIEW OF LITERATURE:
Lam D et al. in a prospective, randomized clinical trial to evaluate the efficacy of sequential intravitreal triamcinolone acetonide followed by Grid Laser for treating Diabetic Macular Edema concluded that combined treatment yielded better CFT reduction or BCVA improvement at 6 months than grid laser alone.
Kang Se et al. in a randomized trial on patients with diffuse macular edema evaluated the clinical outcome of macular grid photocoagulation after intravitreal injection of 4mg Triamcinolone acetonide for diffuse diabetic macular edema and concluded that macular laser coagulation effectively maintains improved visual acuity after IVTA and is believed to reduce recurrent Diabetic Macular Edema after IVTA Massin P et al. In a prospective study to evaluate the efficacy and safety of intravitreal injection of 4mg of triamcinolone acetonide for refractory diffuse macular edema, concluded that intravitreal injection of triamcenolone effectively reduces macular thickening due to diffuse diabetic macular edema.
7 MATERIAL AND METHODS:
7.1, SOURCE OF DATA:
Patients attending vitreoretinal clinic of Minto Ophthalmic Hospital from Dec 2008 to Nov 2009.
7.2, METHOD OF COLLECTION OF DATA:
It is a hospital based non-randomized, prospective case series of 50 eyes of 50 patients with diabetic macular edema. After written and informed consent , patients will be subjected to intravitreal injection of 4mg triamcenolone acetonide followed by laser photocoagulation four weeks later after assessment of CFT by OCT. The schedule of examination will be: (1) Next day of procedures, (2) After 3 wks, 3months and 6 months of IVTA
Inclusion criteria:
. Diabetic macular edema with zone or zones of retinal thickening one disc area, or larger at any part within one disc diameter of center or macula e.g. cystoid macular edema, spongy edema, etc.
. Diffuse leakage involving center of macula on fluorescein angiography.
. Center foveal thickness >= 250microns as measured by optical coherence tomography (OCT).
Exclusion criteria:
. Macular edema with proliferative diabetic retinopathy
. Diabetic macular edema with macular ischemia >= 1disc diameter.
. Diabetic Macular edema with pre-existing glaucoma.
. Patient with dense media due to cataract, vitreous haemorrhage etc.
. Macular edema with vitreo retinal traction.
. Patients having undergone prior laser or IVTA therapy within six months. 7.3, DOES THE STUDY REQUIRES ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? (IF SO, PLEASE SPECIFY)
Yes the study involves the following investigations and interventions on patients.
1. INVESTIGATIONS:
Visual acuity by Snellens chart
Refraction and correction
Anterior segment examination by slit lamp biomicroscopy
Applanation tonometry for intra ocular pressure measurement
Gonioscopy
Fundus examination with indirect ophthalmoscope, 90 D, 78 D
Optical Coherence Tomography (OCT)
Fundus Fluorescein Angiography (FFA)
INTERVENTIONS:
Intravitreal injection of Triamcinolone Acetonide 4mg in 0.1ml under strict aseptic condition
Laser photocoagulation
7.4. HAS THE ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN
CASE OF 7.3?
Yes
8 LIST OF REFERENCES:
8.1 TEXT BOOK REFERENCES:
1. Yanoff Myron.M .D., Duker Jay S. “Ophthalmology” Second edition, Mosby International Ltd. 2004: Chap 117, Pg 879-888 2. Kanski Jack J. “Clinical Ophthalmology” Sixth edition, Butterworth Heinemann, 2007: Chap 16, Pg 566-584
3. Olk Joseph R., Lee Carol M. “Diabetic Retinopathy”, Lippincott Company: Chap 5, Pg. 51-84
4. Tso Mark O M,“Retinal Diseases”,Lippincott Company: Chap 15, Pg 247-262
5 Ryan Stephen J,“Retina” Mosby Company:chapter 70:Pg 301-326
8.2 JOURNAL REFERENCES :
6. Lam Dennis S.C.,Mohamed Shaheeda, Liu David T.L., Shanmugam Mahesh P. Intravitreal Triamcinolone plus Sequential Grid Laser versus Triamcinolone or Laser Alone for Treating Diabetic Macular Edema. Ophthalmology 2007;114:2162-2167
7. Kang SW, Ho-Seok S, Cho HY, Kim JI. Macular grid photocoagulation After Intravitreal Triamcinolone acetonide for Diffuse Diabetic Macular Edema. Arch Ophthalmol 2006;124:653-658
8. Iida T. Combined triamcinolone acetonide injection and grid laser photocoagulation: a promising treatment for diffuse diabetic macular edema? Br. J. Ophthalmol.2007;91:407-408.
9. Early Treatment Diabetic Retinopathy Study Research Group.Photocoagulation for diabetic macular edema. Early Treatment diabetic retinopathystudy report number 1.Arch Ophthalmol 1985;103:1796-806.
9 SIGNATURE OF CANDIDATE :
Dr Kumar Ravi
10. REMARKS OF THE GUIDE: Diabetic macular edema is a major cause of vision loss in diabetic population. ETDRS study has shown that 50% of patients did not benefit from routine photocoagulation. The limited efficacy of laser photocoagulation on diffuse macular edema has drawn attention to alternative treatments.
Combined therapy of intravitreal triamcinolone and laser is expected to significantly improve visual acuity in diffuse diabetic macular edema, where laser alone may not be sufficient. Combination therapy also overcomes the disadvantage of short duration of action of triamcinolone acetonide alone.
Therefore, there is a need to study the efficacy of this therapy in our set up.
11. NAME AND DESIGNATION OF THE:
11.1 GUIDE: DR. SUJATHA. B. L. M.B.B.S., M.S.(Oph.) M.Sc.(CEH) LONDON, FVR (RGUHS)
PROFESSOR,
DEPT. OF COMMUNITY OPHTHALMOLOGY,
MINTO OPHTHALMIC HOSPITAL,
BANGALORE MEDICAL COLLEGE AND RESEARCH
INSTITUTE
11.2 SIGNATURE:
11.3 CO GUIDES IF ANY: NONE
11.4 SIGNATURE:
11.5 HEAD OF DEPARTMENT : DR . K. S. SRIPRAKASH M.B.B.S. , M.S. (OPH) ,
CHIEF, VITREO RETINAL SERVICES,
MEDICAL SUPERINTENDENT ,
PROFESSOR AND HEAD OF DEPARTMENT,
DEPARTMENT OF OPHTHALMOLOGY,
MINTO OPHTHALMIC HOSPITAL ,
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE,
BANGALORE – 560 002
11.6 SIGNATURE :
12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL:
12.2 SIGNATURE :