Degenerative conditions of the eyeball

CLINICAL PROTOCOL FOR DIAGNOSIS AND TREATMENT

DIAGNOSIS AND TREATMENT AT OUTPATIENT LEVEL: 1) Diagnostic criteria [2]: Complaints: absence of vision; cosmetic defect in the form of drooping of the upper eyelid; lacrimation; photophobia in the fellow eye. History: previous trauma, burn/severe inflammation of the eye (uveitis). Physical examination: none. Laboratory investigations: bacteriological culture from the conjunctival cavity with identification of

the causative agent and determination of antibiotic sensitivity. Instrumental investigations: Visometry: absence of vision, possible reduction of vision in the fellow eye. Biomicroscopy condition of the eyelids and conjunctival fornices: upper eyelid is drooping, palpebral fissure is covered, fornices are deep, sometimes scars. Tonometry (non-contact). Ultrasound examination of the eyeball: assess the condition of the posterior segment: destruction, exudate, hema, retinal detachment, fibrosis of membranes. Electrophysiological examination of the eye: approximate vision, functional activity of the retina and conductivity of the optic nerve, sympathetic irritation in the fellow eye 2) Diagnostic algorithm: see appendix 1.

3) Differential diagnosis and justification for additional investigations[8,11,12]:

3

Diagnosis Justification for Investigations Exclusion criteria differential diagnosis

Approved by the Joint Commission on Quality of Medical Services of the Ministry of Health and Social Development of the Republic of Kazakhstan

dated September 8, 2016, Protocol No. 16

DEGENERATIVE CONDITIONS OF THE EYEBALL

Contents:

Correlation of ICD-10 and ICD-9 codes 1 Date of development 2 Protocol users 2 Patient category 2 Evidence level scale 2 Definition 2 Classification 2

Diagnosis and treatment at the outpatient level

3

Diagnosis and treatment at the emergency care stage

5

Diagnosis and treatment at the inpatient level

Medical rehabilitation

9 Palliative care 9 Abbreviations used in the protocol 9 List of protocol developers 9 Conflict of interest 9 List of reviewers 10 List of references 10 1

Correlation of ICD-10 and ICD-9 codes:

ICD-10

ICD-9

Code Name Code Name H44.5 Degenerative conditions of 16.49 Eviscerenucleation the eyeball H44.3 Other degenerative

Eviscerenucleation with

diseases of the eyeball formation of a voluminous and mobile stump

Date of protocol development: 2016.

Protocol users: ophthalmologists.

Patient category: adults.

Evidence level scale: A High-quality meta-analysis, systematic review of RCTs or large RCT with very low probability (++) of systematic error, the results of which can be applied to the relevant population. B High-quality (++) systematic review of cohort or case-control studies or high-quality (++) cohort or case-control studies with very low risk of systematic error or RCT with low (+) risk of systematic error, the results of which can be applied to the relevant population. C Cohort or case-control study or controlled study without randomization with low risk of systematic error (+). The results of which can be applied to the relevant population or RCT with very low or low risk of systematic error (++ or +), the results of which cannot be directly applied to the relevant population. D Description of case series or uncontrolled study or expert opinion.

diagnosis

Keratitis Complaints of Biomicroscopy, On biomicroscopy: lacrimation, echobiometry, B- presence of corneal photophobia, scan infiltrate, discharge, de-epithelialization without decreased vision, tissue defect, pain syndrome.

ulceration.

On biomicroscopy – presence of corneal edema, corneal infiltrate Ptosis Complaints of Biomicroscopy, On biomicroscopy: (blepharoptosis) drooping of the upper echobiometry, B- eyeball size eyelid.

scan unchanged, cornea transparent.

Congenital Complaints of Biomicroscopy, On biomicroscopy: microphthalmos congenital echobiometry, B- presence of reduced reduced scan eyeball eyeball or , shortening its absence of conjunctival fornices, shortened width of palpebral fissure.

4) Treatment tactics:

Non-drug treatment: none. Drug treatment: none. Algorithm of actions in emergency situations: none Other types of treatment: none.

5) Indications for specialist consultations: in the presence of concomitant pathology.

6) Preventive measures: none. 7) Patient condition monitoring: none. 8) Treatment effectiveness indicators: none.

DIAGNOSIS AND TREATMENT AT THE EMERGENCY CARE STAGE: 1) Diagnostic measures: none. 2) Drug treatment: none.

DIAGNOSIS AND TREATMENT AT THE INPATIENT LEVEL: 1) Diagnostic criteria at the inpatient level [2,3]:

Complaints and medical history: see section 9 subsection 1.

Physical examination: none.

Laboratory tests: see section 9 subsection 1.

Instrumental studies: see section 9 subsection 1.

2) Diagnostic algorithm: see Appendix 1.

3) List of main diagnostic measures [3]: lacrimal duct irrigation; ophthalmoscopy; ultrasound of the eyeball.

4) List of additional diagnostic measures: EFI with determination of approximate VIS, ERG, VEP; cycloscopy of the fellow eye.

5) Treatment tactics: in order to eliminate the threat of sympathetic irritation of the fellow eye, eliminate cosmetic discomfort, relieve pain syndrome, surgical treatment is performed – eviscerenucleation with formation of a voluminous stump;

–– Non-drug treatment: General regimen 3.

5 Diet No. 15.

–– Drug treatment: in the presence of concomitant high intraocular pressure, beta-blockers are used; for prevention of postoperative inflammatory process – topical antibiotics.

Drug Pharmacological Route of Single dose and Durati UE substance groups administration frequency on of

(INN)

of use treatm ent course Dexamethaso Glucocorticoids Instillations 2 drops, 3

UE – C

ne for topical use in into the 4-6 times daily weeks [15,16] suspension in ophthalmology conjunctival after surgery eye drops sac and then 0.1% 5 ml according to decreasing regimen Dexamethaso Glucocorticoids Parabulbar or 0.5 – 1.0 ml,

days UE – C

ne solution for subconjunctiv once daily [15,16] for systemic use al injections injections 0.4% 1 ml Prednisolone solution for injections 30 mg/ml Levofloxacin eye drops 0.5% 5 ml

or

Tobramycin eye drops 5 ml

Glucocorticoster oids

Antimicrobial drug of the fluoroquinolone group for topical use in ophthalmology Antimicrobial drug of the aminoglycoside group for topical use in

Intramuscula rly

Instillations into the conjunctival sac

Instillations into the conjunctival sac

mg, once daily

drops, 6 times daily

drops, 6-8 times daily

days UE – C [15,16]

days [17] 10

UE – B

days [27] 6

Timolol eye drops 0.5%

Sodium hyaluronate

Proxymetaca ine, eye drops 15 ml

Lidocaine solution for injections 2%

Atropine sulfate solution for injections 1 ml 1 mg/ml Diphenhydra mine ampoules 1 ml

ophthalmology Beta-blocker

tear film protector

Local anesthetic agent

Local anesthetic agent

Belladonna alkaloid, tertiary amines

Antihistamine drug

Topically 2 drops, conjunctival sac 2 times Instillations 2 drops, into 3-4 times a day conjunctival sac Instillations 2 drops, into

times

conjunctival sac For 0.5 ml, parabulbar 1 time per day and subconjunctival injections Premedication Intramuscularly 1 ml,

Intramuscularly 0.3 ml, 1 time – premedication Intravenously 0.5 ml, 1 time –ataralgesia Up to 7 LE – B days [29, 30] 1-2

LE – B

months [25, 26]

days LE – B [22-24]

days LE – B [31,32]

days LE – GPP

Tramadol Opioid ampoules 1 narcotic ml analgesics Fentanyl Analgesic.

0.005% 1 ml Opioids.

Phenylpiperidine derivatives Anesthesia Intramuscularly 1 ml, Intravenously 1.0 ml, 1 time

days LE – C [22, 33]

days LE – B [22,34, 35]

7 Trimeperidine Opioid narcotic

ml

analgesics Propofol Anesthetic emulsion 20 agents ml Intramuscularly 1.0 ml, Intravenously 200 mg, 1 time

LE – C [22, 38, 39]

List of essential medicines: dexamethasone; levofloxacin; proxymetacaine; sodium hyaluronate. List of additional medicines: tobramycin; prednisolone; timolol; lidocaine; atropine sulfate; diphenhydramine; tramadol; fentanyl; trimeperidine; propofol.

Surgical intervention (LE - B) [3,5,6,7,8]: Types of surgery: evisceroenucleation with formation of a voluminous and mobile stump; Purpose: prevention of development of sympathetic inflammation in the fellow eye, creation of conditions for ocular prosthetics, by forming a support-mobile stump. Indications: presence of signs of sympathization in the fellow eye; absence of conditions for ocular prosthetics; absence of visual functions: VIS = 0 (zero). Contraindications: presence of somatic pathology, with contraindication to anesthetic support.

6) Indications for specialist consultations [2,3]: in the presence of concomitant pathology.

7) Indications for transfer to intensive care and resuscitation unit: none.

8) Indicators of treatment effectiveness (LE - B) [5,6,7,8]: relief of signs of sympathetic inflammation in the fellow eye; creation of optimal conditions for ocular prosthetics.

9) Further management: outpatient observation by ophthalmologist at place of residence 2 times per year.

13. MEDICAL REHABILITATION: none.

14. PALLIATIVE CARE: none.

Abbreviations used in the protocol:

VIS AB GCS VEP ELISA US ERG EPE LE INN

• visual acuity – antibiotics – glucocorticosteroids – visual evoked potential – enzyme-linked immunosorbent assay – ultrasound examination – electroretinography – electrophysiological examination – level of evidence – international nonproprietary name

List of protocol developers: 1) Dzhumataev Erik Asylkhanovich – Candidate of Medical Sciences, JSC "Kazakh Research Institute of Eye Diseases" ophthalmologist of the highest category. 2) Niyazov Ilzat Azimzhanovich – JSC "Kazakh Research Institute of Eye Diseases" ophthalmologist of the highest category of the prosthetics department. 3) Odintsov Konstantin Vladimirovich – JSC "Kazakh Research Institute of Eye Diseases" branch in Astana city, ophthalmologist. 4) Sultankulova Banu Tastemirovna – JSC "Kazakh Research Institute of Eye Diseases" ophthalmologist of the consultative-rehabilitation department.

5) Smagulova Gaziza Azhmagieva – Candidate of Medical Sciences RSE on REM "West Kazakhstan State Medical University named after Marat Ospanov", associate professor, head of the department of propaedeutics of internal diseases and clinical pharmacology.

1. Indication of absence of conflict of interest: none.

1. List of reviewers: Kurmangalieva Madina Maratovna – Doctor of Medical Sciences, RSE on REM "Hospital of the Medical Center of the Administration of the President of the Republic of Kazakhstan", chief ophthalmologist.

1. List of references:

1) Avetisov S.E., Kashchenko T.P., Shamshinova A.M. Visual functions and their correction in children. M.: Medicine. — 2005.

2) Shif L.V. Ocular prosthetics - M.: Medicine 1981. P.135 3) Druyanova Yu.S., Shif L.V. On the mobility of ocular prostheses// Ophthalmol.

journal. – 1976 №6 P. 448.

4) Druyanova Yu.S., Morozova O.D. Prosthetics of congenital microphthalmos and anophthalmos// Vestn. ophthalmol. – 1981 №3 P. 65 – 66.

5) Filatova I. A. Anophthalmos. Pathology and treatment. Moscow 2007

6) Fedorov S.N., Cheglakov Yu.A., Lyaskovik A.Ts., Kozhukhov A.A. Surgical interventions on eyes that have lost visual function. –Method.rec. 1995 P. 18 7) Gundorova R.A., Verigo E.N., Kataev M.G., Druyanova Yu.S., Florov-Bagreev M.N. Methods of stump formation after enucleation and primary ocular prosthetics: Method rec. – Moscow,1999. P13.

8) Kopaeva V.G. Eye diseases. M.: Medicine, 2002.

9) Gundorova R.A. Fundamentals of organization of ocular prosthetics service//Vestn.

Ophthalmol. – 1986 № 2 10) Zaykova M. V. Plastic ophthalmic surgery//M.: Medicine 1980 P. 207 11) Taylor D., Hoyt C. Pediatric ophthalmology (translated from English). Saint- Petersburg.: Binom, 2002.

12) Callahan A. Surgery of eye diseases// M.: Medicine 1963.

13) Morax S. Orbito-palpebral reconstructions in severe congenital anophthalmos and microphthalmos// Ann.Chir.Plast.Esthet. – 1987. V32. №3. P.255 – 261.

14) O`Keefe M., Webb M., Pashby R. C. Wagman R.D. Clinical anophthalmos// Br.J.Ophthalmol. – 1987. V.71 № 8. P. 635-638.

15) Dina Gewaily ,KarthikeyanMuthuswamy and Paul B Greenberg.Intravitreal steroids versus observation for macular edema secondary to central retinal vein occlusion. Cochrane Database of Systematic Reviews. Online Publication Date: September 2015.Available from: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD007324.pub3/full 16) Christopher J Brady, Andrea C Villanti, Hua Andrew Law, EhsanRahimy, Rahul Reddy, Pamela C Sieving, Sunir J Garg and Johnny Tang. Corticosteroid 10 implants for chronic non-infectious uveitis. Cochrane Database of Systematic Reviews.

Online Publication Date: February 2016. Available from: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD010469.pub2/full 17) Emily W Gower, Kristina Lindsley, Afshan A Nanji, IlyaLeyngold and Peter J McDonnell. Perioperative antibiotics for prevention of acute endophthalmitis after cataract surgery. Cochrane Database of Systematic Reviews.Online Publication Date: July 2013.

Available from: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006364.pub2/full 18) Briscoe D, Edelstein E, Zacharopoulos I, Keness Y, Kilman A, Zur F, Assia EI.

Actinomycescanaliculitis: diagnosis of a masquerading disease. Graefes Arch ClinExpOphthalmol. 2004 Aug;242(8):682-6. Epub 2004 Jun 19) Siderov J and Nurse S. The mydriatic effect of multiple doses of tropicamide.Optometry and vision science : official publication of the American Academy of Optometry, 2005, 82(11), 955 20) Bolt B, Benz B, Koerner F and Bossi E. A mydriatic eye – drop combination without systemic effects for premature infants: a prospective double-blind study.Journal of pediatric ophthalmology and strabismus, 1992, 29(3), 157 21) Stavert B, McGuinness MB, Harper CA, Guymer RH, Finger RP.Cardiovascular Adverse Effects of Phenylephrine Eyedrops: A Systematic Review and Meta-analysis.

JAMA Ophthalmol. 2015 Jun;133(6):647-52. doi: 10.1001/jamaophthalmol.2015.0325.

22) C M Kumar, T Eke,CDodds,J S Deane,et al. Local anaesthesia for ophthalmic surgery—new guidelines from the Royal College of Anaesthetists and the Royal College of Ophthalmologists. Eye (Lond). 2012 Jun; 26(6): 897–898. Published online 2012 Apr

doi: 10.1038/eye.2012.82

23) Swaminathan A, Otterness K, Milne K, Rezaie S. The Safety of Topical Anesthetics in the Treatment of Corneal Abrasions: A Review. J Emerg Med. 2015 Nov;49(5):810-5. doi: 10.1016/j.jemermed.2015.06.069. Epub 2015 Aug 15.

24) Davis MJ, Pollack JS, ShottS.Comparison of topical anesthetics for intravitrealinjections : a randomized clinical trial. Retina. 2012 Apr;32(4):701-5. doi: 10.1097/IAE.0b013e31822f27ca.

25) Johnson ME, Murphy PJ, Boulton M. Effectiveness of sodium hyaluronateeyedrops in the treatment of dry eye. Graefes Arch ClinExpOphthalmol. 2006 Jan;244(1):109-12. Epub 2005 Jun 28.

26) Lee JH, Ahn HS, Kim EK, Kim TI. Efficacy of sodium hyaluronate and carboxymethylcellulose in treating mild to moderate dry eye disease. Cornea. 2011 Feb;30(2):175-9. doi: 10.1097/ICO.0b013e3181e9adcc.

27) Kernt K, Martinez MA, Bertin D, Stroman D, Cupp G, Martínez C, Tirado M, Guasch J and International Tobrex2x Group (Eu). A clinical comparison of two formulations of tobramycin 0.3% eyedrops in the treatment of acute bacterial conjunctivitis.European journal of ophthalmology, 2005, 15(5), 541 28) Gentile RC, Shukla S, Shah M, Ritterband DC, Engelbert M, Davis A, Hu DN.

Microbiological spectrum and antibiotic sensitivity in endophthalmitis: a 25-year review.

Ophthalmology. 2014 Aug;121(8):1634-42. doi: 10.1016/j.ophtha.2014.02.001. Epub 2014 Apr 2. 29) Li T, Lindsley K, Rouse B, Hong H, Shi Q, Friedman DS, Wormald R, Dickersin K. Comparative Effectiveness of First-Line Medications for Primary Open-Angle Glaucoma: A Systematic Review and Network Meta-analysis. Ophthalmology. 2016 Jan;123(1):129-40. doi: 10.1016/j.ophtha.2015.09.005. Epub 2015 Oct 31. 30) Dayse F Sena and Kristina Lindsley. Neuroprotection for treatment of glaucoma in adults. Cochrane Database of Systematic Reviews. Online Publication Date: February 2013. Available from: http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006539.pub3/full 31) North RV, Kelly ME. A review of the uses and adverse effects of topical administration of atropine. Ophthalmic Physiol Opt. 1987;7(2):109-14. 32) Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D.Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropinefor the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2. 33) Delgado C, Bentley E, Hetzel S, Smith LJ. Comparison of carprofen and tramadol for postoperative analgesia in dogs undergoing enucleation. J Am Vet Med Assoc. 2014 Dec 15;245(12):1375-81. doi: 10.2460/javma.245.12.1375. 34) ZöllnerC, Mousa S, Klinger A, Förster M and Schäfer M. Topical fentanyl in a randomized, double-blind study in patients with corneal damage. The Clinical journal of pain, 2008, 24(8), 690 35) Sato Y, Oshiro M, Takemoto K, Hosono H, Saito A, Kondo T, Aizu K, Matsusawa M, Futamura Y, Asami T, Terasaki H, Hayakawa M. Multicenter observational study comparing sedation/analgesia protocols for laser photocoagulation treatment of retinopathy of prematurity. J Perinatol. 2015 Nov;35(11):965-9. doi: 10.1038/jp.2015.112. Epub 2015 Sep 10. 36) HolasA, Krafft P, Marcovic M and Quehenberger F. Remifentanil, propofol or both for conscious sedation during eye surgery under regional anaesthesia.European journal of anaesthesiology, 1999, 16(11), 741 37) Fulton B, Goa KL. Propofol. A pharmacoeconomic appraisal of its use in day case surgery. Pharmacoeconomics. 1996 Feb;9(2):168-78. 38) Greenhalgh DL, Kumar CM. Sedation during ophthalmic surgery. Eur J Anaesthesiol. 2008 Sep;25(9):701-7. doi: 10.1017/S0265021508004389. Epub 2008 May 9. 39) Woo JH, Au Eong KG, Kumar CM. Conscious sedation during ophthalmic surgery under local anesthesia. Minerva Anestesiol. 2009 Apr;75(4):211-9. Epub 2008 Nov 6.

12

Data from medical history regarding the presence of trauma, burn or inflammatory process

Diagnostic algorithm: (scheme)

EYEBALL

CONSULTATION IN OPHTHALMOLOGICAL

CENTERS

Appendix 1

Time elapsed since trauma, burn, or inflammatory process

RECOMMENDED

EVISCEROENUCLEATION

Absence of inflammatory process for one month and

ocular prosthetics High probability of sympathetic inflammation in the

fellow eye

Performing evisceroenucleation Signs of sympathetic inflammation according to electrophysiological examination data 13

Indications for Hospitalization

INDICATIONS FOR HOSPITALIZATION WITH INDICATION OF HOSPITALIZATION TYPE [3,5,6,7,8]: 10.1 Indications for planned hospitalization:

reduction in size of the eyeball; drooping of the upper eyelid, narrowing of the palpebral fissure; absence of vision; absence of optimal conditions for ocular prosthetics; signs of sympathetic irritation in the fellow eye.

Indications for emergency hospitalization: none.

Referral for Surgical Treatment

Observation at Place of Residence