Bangalore, karnataka. Annexure -II proforma for registration of subject for dissertation



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

ANNEXURE –II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION



1.


Name of the candidate and Address

DR. MANASA PENUMETCHA

PG MS OPHTHALMOLOGY

BMCRI,BANGALORE




2.


Name of the institution

BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE, BANGALORE-560002




3.


Course of Study and Subject

M.S. IN OPHTHALMOLOGY




4.


Date of Admission to course

22ndJUNE 2013




5.


Title of the topic

TO ASSESS THE SAFETY AND EFFICACY OF 23 GAUGE THREE PORT PARS PLANA VITRECTOMY FOR NON RESOLVING VITREOUS HAEMORRHAGE






6.

Brief resume of intended work





6.1. Need for study:
Vitreous haemorrhage is defined as the presence of extravasated blood within the vitreous cavity1.It is one of the most common disorders presenting to retina clinic with acute visual loss. Vitrectomy is done in vitreous haemorrhage secondary to conditions that cause retinal neovascularisation like in proliferative diabetic retinopathy ,vein occlusions and vasculitis or choroidal neovascularization like age related macular degeneration , pathologies of vitreoretinal interface like posterior vitreous detachment, trauma and neoplasia.2
The recent evolution in pars plana vitrectomy is minimal invasive small gauge 23 and 25 gauge vitrectomy systems which are safe and effective and provide numerous potential advantages over traditional 20 gauge vitrectomy system3. 23 and 25 gauge make small self sealing sutureless transconjunctival pars plana sclerotomies which minimize surgical trauma to conjunctiva and sclera and hence faster wound healing , reduced post operative astigmatism , faster visual recovery , improved patient comfort and decreased post operative inflammation.3
The vitreoretinal instruments used in 25 gauge series were too flexible as compared with 23 gauge instruments which made it impossible to guide the eye during manipulation in the far periphery. Also, 23 gauge systems have better fluidics hence reducing operating time. Post operative hypotony was noted in both but less frequent in 23 gauge series.4-8
Thus 23 gauge technique shows a capability to replace both 25 gauge and the standard 20 gauge technique offering benefits of both sutureless system and sturdier and larger instrument action .9

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6.2. Review of literature:

Samuel boyd et al. Vitrectomy is done in vitreous haemorrhage secondary to conditions that cause retinal neovascularisation like in proliferative diabetic retinopathy ,vein occlusions and vasculitis or choroidal neovascularization like age related macular degeneration , pathologies of vitreoretinal interface like posterior vitreous detachment, trauma and neoplasia.2


Stephen J Ryan stated in vitreoretinal surgery the attractiveness of smaller gauge vitrectomy instrument system is based on ability to minimize surgery induced trauma from conjunctival peritomy and sclerotomy sites, allow self sealing sclerotomies ,improve operative efficacy and hasten post operative recovery.10

Fujii GY et al conducted retrospective review of a consecutive interventioal case series on Initial experience using transconjunctival sutureless vitrectomy system for vitreoretinal surgery and concluded 25 gauge transconjunctival sutureless vitrectomy to be practical and safe for a variety of vitreoretinal procedures. The concept of transconjunctival sutureless surgery has the potential to increase the efficacy of a variety of vitreoretinal surgery and possibly hasten the post operative recovery and outcomes in several conditions by simplifying the surgery procedure, minimizing surgery induced trauma and the convalescence period , the operating time and postoperative inflammatory response.3

Jose G.Arumi et al on transconjunctival sutureless 23 gauge vitrectomy for diabetic retinopathy and S.Rizzo et al. concluded that the 23 gauge system obviates some of the shortcomings of 25 gauge systems since the instruments are less flexible and perform more like 20 gauge instruments allowing more thorough peripheral vitrectomy and highly complex maneuvers. This instrument creates tunneled sclerotomies that provides a self sealing incision. Moreover the fact that the cutting part of the vitrector is closer to the tip is particularly useful in cases of proliferative diabetic retinopathy.4,5

Huma kayani et al concluded 23 gauge vitrectomy system offers advantage of sutureless system ,larger and stiffer instrumentation while both 23 and 25 gauge induce minimal ocular trauma, decrease inflammatory response and allows faster patient and visual recovery.6

Mishra A , Ho Yen G et al. did a study on 23 gauge sutureless vitrectomy and 20 gauge vitrectomy: A case series comparision and Tomic Z et al. on Comparision between 25 gauge and 23 gauge sutureless vitrectomy techniques. And concluded less risk of raised Intra ocular pressure and decreased surgical operating time with the 23 gauge system. Additional advantages observed included faster wound healing, diminished conjunctival scarring, improved patient comfort and decreased post operative inflammation7,8

Keith warren concluded 23 gauge instrument provides an effective and safe alternative for sutureless surgeries. The intermediate gauge seems to offer advantages over other sizes of instrumentation.9


Post surgical endophthalmitis is suspected to be more frequent after microinsional(23- and 25-gauge)compared with standard(20 –gauge)vitrectomy. Govetto A and Virgili G on A systematic review of endophthalmitis after microincisional versus 20 gauge vitrectomy concluded that there is no increased risk of endophthalmitis for microincisional vitrectomy compared with standard vitrectomy. The bevelled approach seems to be safer than a straight approach, supporting the current recommendation of its adoption in microincisional vitrectomy11

6.3. Aims and Objectives of the study:

1. To study the efficacy following three port parsplana 23 gauge vitrectomy for non resolving vitreous haemorrhage

2. To study the post operative complications of the procedure.


MATERIALS AND METHODS:
7.1. Source of data:
Patients coming to Retina clinic Minto Ophthalmic Hospital, Regional Institute of Ophthalmology attached to Bangalore Medical College and Research Institute.

7.2. Method of collection of data:
A.Study design: Hospital based, non randomized, interventional, prospective study.
B.Study period: October 2013-May 2015.
C.Place of study: Minto Ophthalmic Hospital, Regional Institute of Ophthalmology attached to Bangalore Medical College and Research Institute.
D.Sample size: 25 eyes fulfilling inclusion/exclusion criteria.


E. Inclusion criteria:


  1. Patients giving written informed consent.(Annexure-1)

  2. Vitreous haemorrhage following severe proliferative diabetic retinopathy

  3. Vitreous haemorrhage following vein occlusions

  4. Vitreous haemorrhage following trauma

  5. Bilateral vitreous haemorrhage with significant decrease in visual acuity

  6. Other non resolving vitreous haemorrhage that is persisting for more than 6-8 weeks


F. Exclusion criteria:

1.Patient not willing for surgery

2.Media opacities like corneal /lenticular opacities obscuring proper view

3.Previous posterior segment surgery



G. Methodology: 25 eyes fulfilling inclusion/exclusion criteria will be included in the study and their demographic data (age, gender, address, occupation) and history will be taken. All subjects will undergo complete ocular examination and systemic evaluation.
1. Best corrected visual acuity

2. Slit lamp Examination

3. Applanation tonometry

4. Posterior segment evaluation by Indirect Ophthalmoscope, Fundus photography, B- Scan

5. Surgical procedure of three port 23 gauge pars plana vitrectomy.

6. Post operative evaluation in terms of visual acuity, corneal clarity, Intraocular pressure, best corrected visual acuity and complications and their management (if any).



H. Statistical method:

The data in this study will be assessed using Student- t test.


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 study involves the following investigations and interventions on patients.




  • Best corrected Visual acuity -Pre and post operatively

  • Slit lamp examination -Pre and post operatively

  • Applanation tonometry - Pre and post operatively

  • Posterior segment evaluation by Indirect Ophthalmoscopy, B- Scan, Fundus photography-Pre and post operatively

  • Surgical Procedure of 3 port pars plana vitrectomy in non resolving vitreous haemorrhage .


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

Yes
LIST OF REFERENCES:




  1. Nan-kai wang et al.Vitreous hemorrhage :Recent and future management,S Natarajan editor,Textbook of vitreoretinal diseases and surgery , 1st edition Jaypee brothers medical publishers(P) ltd;2009.107-108



  1. George B. Peters III, et al. Management of intraocular hemorrhage and other complications, Samuel boyd editor. Retinal and vitreoretinal diseases and surgery.1ST edition . Jaypee-Highlights medical publishers,Inc; 2010. 507-519



  1. Fujii GY,De juan E Jr,Humayun MS,Chang TS ,Pieramici DJ,Barnes A,Kent D. Initial experience using the transconjunctival sutureless vitrectomy for vitreoretinal surgery Ophthalmology.2002 ;109:1814-20




  1. Jose G. Arumi, Anna boix adera,Vicente Martinez-castillo and Bozra Corcostegui.

Transconjunctival sutureless 23 gauge vitrectomy for diabetic retinopathy.Current diabetes reviews 2009,5,63-66



  1. Stanislao Rizzo, Small gauge vitrectomy:which caliper should we choose and when.S.Rizzo editor, Vitreo retinal surgery progress 3,1st edition ,2009;208-11




  1. Huma kayani, Amir ahmed, Kashif Jahangir, Hizb-ur-rehman, Khurram chauhan. Comparision between 23 gauge and 25 gauge parsplana vitrectomy for posterior segment disease, Pak J Ophthalmol 2013 Vol29 No.1 40-45




  1. Mishra A ,Yen GH,Bruton RL.23 Gauge sutureless vitrectomy :A Case series comparision. Eye 2009;23:1187-91




  1. Tomic Z, Gili JN, Theocharis I .Comparision between 25 gauge and 23 gauge sutureless vitrectomy techniques.Retina today 2007;4(1)




  1. Keith warren. 23 gauge vitrectomy for sutureless vitreous surgery. Retina today.2008;85-87




  1. Eugene de Juan, Jr et al.25 gauge tras conjunctival sutureless vitrectomy, Stephen J Ryan editor,Retina 4th Edition,2006 ;2575-2583




  1. Govetto ,Virgili et al on Systematic review of endophthalmitis after microincisional Vs 20 gauge vitrectomy, American academy of ophthalmology 2013;40-47


SIGNATURE OF THE CANDIDATE:

DR. MANASA PENUMETCHA
REMARKS OF THE GUIDE: Vitreous haemorrhage is one of the common cause of acute visual loss .Non resolving vitreous haemorrhage is managed by pars plana vitrectomy.

In the era of micro incisional surgeries MicroIncisional Vitrectomy Surgery(MIVS) has the advantages of faster wound healing, decreased post operative inflammation and astigmatism, less operating time and improved patient comfort with best visual outcome.

Complications like post operative hypotony and endophthalmitis are known to occur with 23 gauge procedure but proper construction of sclerotomy wound can overcome these complications.

Hence this study to assess the safety and efficacy of 23 gauge vitrectomy in non resolving vitreous hemorrhage is very much recommended.



NAME AND DESIGNATION
11.1.Guide: DR. SHASHIDHAR S.

MBBS MS (Ophthalmology), FVR

Assistant Professor of Ophthalmology

Minto Ophthalmic Hospital, Regional

Institue of Ophthalmology

Bangalore Medical College & Research

Institute

Bangalore – 560002



11.2. Signature:

11.3 Co-guide (if any): None

11.4. Signature: Not applicable


11.5.Head of the Department: PROF DR T.K.RAMESH

MS OPHTHALMOLOGY,DNB,FRCS

Head of Department(ophthalmology).

Minto Ophthalmic Hospital, Regional Institute

of Ophthalmology.

Bangalore Medical College & Research Institute.

Bangalore.
11.6. Signature:

DEAN & DIRECTOR

PROF DR RAVIPRAKASH D

Dean & Director

Bangalore Medical College & Research

Institute.

Bangalore.

12.1)Remarks of the Dean & director

12.2 Signature of Dean & director :


ANNEXURE I

I, Mr/Mrs/Ms __________________________, exercising my own free will power of choice, hereby give consent for myself as an object in the study TO ASSESS THE SAFETY AND EFFICACY OF 23 GAUGE 3 PORT PARS PLANA VITRECTOMY IN NON RESOLVING VITREOUS HAEMORRHAGE conducted by Asst. Prof. Dr. Shashidhar S., Dr.Manasa penumetcha, Department of Ophthalmology, Minto Ophthalmic Hospital, Regional Institute of Ophthalomology attached to Bangalore Medical College and Research Institute, Bangalore.

The attending doctors have informed me to my satisfaction and in the language best understood by me, the purpose of this study, the materials to be used during the course of this study as well as the side effects/complications like bleeding, infection, endophthalmitis, panophthalmitis, hypotony, pthysis bulbi, secondary glaucoma, uveitis, choroidal detachment, retinal detachment, cystoids macular edema, need for resurgery at a later date etc. and also about the guarded visual prognosis associated with the methods/tools to be used.

I shall not hold doctors or the hospital staff responsible for any untoward consequences.

I am also aware of my right to opt out of the study without prejudice to further treatment at any time during the course of the study without having to give reasons to do so.

Signature of attending doctor Signature/Left thumb impression of patient

DATE:

Signature of Witness:



DATE:


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