The fitting manufacture shall include one or several of the following finished products:

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1 MINIMUM STANDARDS DOCUMENT OCULARISTS ASSOCIATION OF SOUTHERN AFRICA 1. METHODOLOGY Most Ocularists utilize one or several combined fitting-manufacture techniques; i.e., the manufacture process is actually begun as a part of the initial fitting procedure and continues until the ocular prosthesis is considered manufactured and adequately fitted in the patient s eye socket or ptisical eye. One Ocularist usually does all of the fittingmanufacture procedures, however, two or more Ocularists may work as a team on one patient, until all of the procedures are all completed. Except as a temporary prosthesis, or in the case of an indigent patient where no custom designed prosthesis can be afforded, there are to be no pre-fabricated or stock eye prostheses fabricated or provided to any individual or dispenser. Within each Ocularists office, fitting / manufacture of each product requires virtually identical materials, but slightly varying in processing time, and exact materials utilized. The fitting manufacture shall include one or several of the following finished products: A. An ocular prosthesis for an enucleated or ecsenterated eye socket, with or without an implant (implant surgically placed by an Ophthalmic surgeon). B. A scleral shell ocular prosthesis for a ptisical, eviscerated, microphthalmic or blind, disfigured globe. C. Custom-made conformers for: 1. post-surgical eye sockets 2. globe shield for eyelid surgery 3. contracted eye socket expansion 4. congenital microphthalmos socket and/or eyelid expansion 5. congenital anophthalmos socket and/or eyelid expansion 6. template for prosthesis-to-implant motility-coupling device placement procedure. D. Enlargement (augmentation) of an ocular prosthesis. E. Reduction of an ocular prosthesis F. Modification of prosthesis for motility-coupling device(s). An eye prosthesis, even when still fitting successfully, has a limited lifespan of five to eight years as the material deteriorates after this time period. Prosthesis should be replaced every five (5) years In the case of children, the prosthesis may need to be replaced anything up to every six months as the child develops Replacement is necessary: 1

2 as a result of the material having deteriorated through age or contamination from external irritants due to the socket having changed after a period of time, or after surgery when mismanagement has caused the material to deteriorate, in cases of contraindicated medication being prescribed, or home remedies used. (when using contra-indicated medications, the patient will need to remove the eye prosthesis for the full duration of administering of the drug/s) Explanation of code grading: points use consultation as base line. Each practice will use its own monetary value for points. In minutes, approximate. Score out of 5, (1 = min; 5 = max) and experience needed for any given task. Score out of 5, (1 = min; 5 = max) of repeating any given task. Score out of 5, (1 = min; 5 = max) Expense of and/or number of pieces of equipment required to achieve any given task. 2. DETAILS Prosthetic Consultation Purpose of Code: A new patient, or a patient who has not been seen by the Ocularist for at least a period of three months. A prosthetic consultation shall include one or several of the following: Patient details including physical and postal contact details Patient history general health, medication, previous surgery, smoker Discussion of patient expectations include: overall cosmesis achievable with fitting-manufacture overall cosmesis with current prosthetic eye in situ prosthetic eye and socket care psychological care 2

3 previous prosthetic fitting where applicable possible cosmetic surgery where applicable cosmetic devices where applicable discussion of future consultations through the process of fitting and manufacture adaptation to eye prosthesis and monocular vision or blindness discussion of realistic costs involved, where possible discussion of realistic life-span of the materials used in manufacture of an eye prosthesis Examination of eye socket including checking of condition of tissue condition of socket, lids and all fornices discharge present implant mobility if applicable insertion of implant surgery applicability movement achievable Where necessary, discussion on Implant and other surgical options available to the particular patient, where applicable showing implants and mobility peg and coupling systems. Where necessary, redirect to Ophthalmologist; Reconstructive Surgeon; Optometrist; parent or guardian; family of patient. Prosthetic Consultation can include photography of any one or several of the above. Discussion on realistic results achievable and all options available. points Impression of Socket to determine the shape and size of the socket for best aesthetic and socketprosthesis related results to determine position and angle of the motiliy/ coupling peg to determine if the shape of the socket has altered since the last prosthesis was fitted The socket shape can change for many reasons, some of which include Soft tissue changes 3

4 Fatty tissue absorption Healing after surgery and/or trauma Change in patients body weight Implant migration The eye socket is inspected for globe or implant position and irregularities in conjunctival tissue and lids. Abnormalities which must be addressed are identified. Various methods are used in taking of impression An appropriate impression shell or conforma is chosen or manufactured and placed into socket (if shell being used) Impression material is placed in shell and then placed into socket or over existing globe OR Shell is placed into eye socket and impression material is introduced into the eye socket behind the shell using a syringe or dental Silicon gun OR Impression of socket over existing prosthesis for building up of prosthesis or positioning of motility peg or the like When the impression material is set, the impression is removed The impression is then invested in an investment medium in preparation for replication Re-inspection of socket is usual, and is needed to check that no impression material is left behind Iris Colour Patient s iris is measured for correct iris & pupil button size and thickness relative to thickness of model. If a flat button is not used, a curved back button may be used if the prosthesis is too thin for a flat button, or if the prosthesis is to made as an extremely thin scleral shell. 4

5 An iris button is either painted or drawn on a suitable material compatible with the MMA scleral colour discussed under 53415, Manufacture of Ocular Porsthesis An iris can be used ex stock or painted or drawn from the patient directly. When painting with MMA, ventilation in the room must be considered Model Manufacture & Fitting A model is made to ascertain the final shape before the prosthesis is manufactured A model is a cheaper version of the final prosthesis since colour and the like are not addressed at this stage. The model is therefore more easily adapted/adjusted than a final eye prosthesis A model may be required to be worn for a period of time for various reasons including swelling, patient adaptation Model manufacture: Replication of impression is done in MMA or similar dental material for models. Model fitting includes: Modification or shaping of model for comfort, socket shape compatibility, best movement achievable, size, symmetry of face and features, eye socket fornices and eye socket irregularities as well as motility peg positioning where necessary. Discussion of realistic results with model in situ, going through the various options with the patient as to where compromises will be necessary. Where patient is not able to participate adequately, the Ocularist may decide which compromises, if any, should be made to comfort, shape, size or movement where all are not equally achievable. 5

6 Marking of model for iris & pupil positioning, anterior and posterior thickness of model and iris location are determined before the model is considered ready for investment Manufacture of Ocular Prosthesis The ocular prosthesis will be the final product. The model indicating pupil/iris positioning is then invested in a dental investment medium for replication in a suitable flask depending on the method of curing to be used. When both sections of the mould are hard, the flask is opened and the prototype model is removed. The iris button is placed in the predetermined location in the anterior section of the mould. Either half of the mould may be enlarged slightly by grinding or scraping or a shimmaterial may be placed between the mould halves if necessary. The mould is cleaned, inspected and a dental separating medium is applied to each side of the mould. Scleral toned MMA powder and monomer are mixed together in a suitable container at a ratio of 3:1 or as per instructions of relevant manufacturer, and shading appropriate to patient. Once the scleral-toned mixture is gelled until it reaches a consistency ranging from dry (i.e. does not stick to the hand) to resembling snappable toffee; the iris button is placed in position and mould is packed with scleral-toned MMA and closed with pressure. Manufacturers instructions are to be adhered to and where vague, South African Dental Association curing methods and times are implemented. 6

7 The moulding flask is then placed in one of the following A. The molding flask is submerged in a water bath and processed in accordance with Specification 12 of the American Dental Association. If using materials requiring different processing times, manufacturer s directions and curing times are to be adhered to. Specification 12 reads in water at 73 C (+/- 1 C) for one and a half hours and then brought to boiling point for a further half hour. When the heating schedule has been completed, the flask shall be cooled in air at 23 C (+/-10 C) for thirty minutes and then immersed in water at 23 C (+/- 10 C) for a further fifteen minutes. B. Microwave Ovens (times and power levels may vary depending on the power rating and wattage and the ballast mass placed in the microwave oven). The specific power of the microwave oven, its model number, brand name as well as levels, curing times and ballast mass shall be indicated on the Medical Device History Record. C. Alternate source of Polymerization Propagation. The chosen methods, time and temperature shall be adhered to and all pertinent information shall be indicated on the Medical Device History Record. All sources of Polymerization propagation are considered curing-units. All batch numbers and curing methods and times shall be indicated on the Patient or Medical Device History Record. The mould is then released from pressure, mould sections separated and prosthesis removed from the mould, excess flashing ground away, iris exposed to proper diameter and scleral area is readied for painting and veining. After veining, the mould is again inspected, repaired, cleaned and a separating medium is applied to both sections. The prosthesis is placed into the posterior section of the mould. Clear PMMA powder and monomer are mixed at the same ratio of 3:1 and gelled as before with Lot and Code numbers recorded on the Patient or medical Device History Record Card. The mixture is then placed on the anterior surface, the mould sections interfaced and closed. The pressurized moulding flask is processed in the curing-unit as before. Once cured, the prosthesis is released from the mould. Flashing and surface irregularities are ground away. It is first polished with a course to gradually finer gradients of polishing materials. See 54215, Polishing. 7

8 53515 Follow-up (within 3 months) A consultation, appointment or check-up within the first three months after Prosthetic Consultation away from Practice Patient may be elderly, ill, or in need of specialist advice or the like. Patient or patients who have not seen an Ocularist for more than three months If the consultation has to take place away from a registered practice or regular satellite practice address. This may be in conjunction with an Opthalmologist or other specialist, at their practice rooms. (The satellite practice address is accepted as a normal address) Consultation as per but including traveling time. Travel costs may include AA rates from practice to consultation and back again. 8

9 53715 Glass Eye, Complete with Consultation and Fitting This form of ocular prosthetic manufacture is not practiced by any South African Ocularists. This art is still performed, on occasion, by visiting Ocularists from other countries. The fitting of glass eyes is considered an old fashioned method of production Drilling of Prosthesis for Ball and Socket Fit to Peg Coupling of the prosthesis to the peg will result in maximum movement being transferred from the implant to the prosthesis. The coupling may also be used to hold the prosthesis in place, and prevent the prosthesis from causing lower lid sagging and the like. Drilling of eye prosthesis for peg coupling to eye prosthesis. Various methods are used for coupling position determination including: Impression of eye socket either on back of prosthesis or with standard shells. Pilot hole drilling used with temporary small headed peg Manual judgment by Ocularist Trimming and Reshaping 9

10 Instead of making a new prosthesis, costs can be saved by adjusting the existing problem. Adjustments made to an existing prosthesis whereby cutting of an eye prosthesis will allow for better fit or cosmesis Build-up As with 53915, costs are saved by working on an existing prosthesis. Adding onto an eye prosthesis usually using wax to build-up for shape and then added to the prosthetic eye in the compatible material. All materials factory specifications must be strictly adhered to Veining To replicate the veins in the sighted eye Procedure; Replication of veins and scleral shading is done from the patient s sighted eye or sample, where necessary. 10

11 Iris tones are enhanced, or applied to anterior surface (if fashioning extremely thin prosthesis), along with the sclera tones and veins. Veining material may be made of nylon, polyester, cotton, silk or pencil crayon. Artwork is then cured onto prosthesis in any of the curing-unit methods Polishing To smooth prosthesis for maximum comfort. To minimize irritation on lid. As a final finish after 53415, Manufacture of an Ocular Porsthesis Final polish of an eye prosthesis or polishing on a yearly basis, is done in order to maintain surface of the prosthesis. A final wet and/or dry high gloss is applied after inspection of all surfaces is complete. There should be no visible defects when examined with a 3x loupe or magnifier. The prosthesis is now ready for disinfection and fitted to the patient. Minor surface reductions may be made during the fitting process, with subsequent repolishing of all surfaces, before the final fitting of the prosthesis. Before final fitting, re-inspection under a 3x loupe or magnifier is required. 11

12 54315 Materials for Custom Made Eye Factory specifications and instructions will be adhered to at all times and with all patients. Materials will vary from practice to practice, but only socket approved dental and ophthalmic supplies may be used.. Records of batch numbers of materials used are to be recorded on patient s card/file Stock Eye Reducing costs to indigent patients. Except as a temporary prosthesis, or in the case of an indigent patient where no custom designed prosthesis can be afforded, there are to be no pre-fabricated or stock eye prostheses fabricated or provided to any individual or dispenser. A stock prosthetic eye may cause irritation to the eye socket or even sinusitis as these prostheses are ill-fitting to the eye socket. The short falls of these cheaper eye prostheses shall be clearly addressed with the patient where a stock prosthesis is fitted. While a stock eye prosthesis is avoided at all costs in most Western countries, it is recognized that there is still a need for the stock eye prostheses in Africa, due to the vast number of indigent patients who would have no other option available to them were the stock eye not available to them. 12

13 54515 Surcharge - Prosthetic Haptic Lens (Shell) This surcharge may be charged when working on a blind eye as the work is often far more difficult on the patient who still has their eye in situ. Increased risks include: taken for appointments taken for fitting and manufacture Increased risk of remaking due to discomfort and fit Increased risk of breakage during any stage of the manufacturing process Motility/Coupling Peg The purpose of a motility/coupling peg is to transfer movement from the implant to the prosthesis. Supply and fitting of a Titanium or other type of peg for use with the implant specific coupling system administered by the Surgeon. 13

14 54715 Conforma Supply & Fit An ex-stock model for use in or after surgery as a temporary socket retention tool whilst socket is healing or while patient is not yet ready for fitting of a final prosthesis for any reason Conforma Supply Only Conforma supplied to Doctor for use in or after surgery as Surcharge children 5 years and under This surcharge may be charged when working on a young patient as the fitting is often far more difficult on the patient who is not yet able to co-operate or fully understand the importance of the work done to achieve a satisfactory end result Increased risks include: taken for appointments taken for manufacture Increased risk of remaking due to lack of co-operation 14

15 55015 Assist in Theatre per 30 minutes May include: Discussion with Ophthalmologist, Reconstructive Surgeon, Anesthetist and/or theatre staff Assist as requested by Doctor, usually in the fitting and shaping of models for reconstructive purposes and/ or Taking of impression for manufacture of model in patients who are not easily able to have this done in practice and/ or Patients who require model fitting for reconstructive purposes Post procedure consultation in ward with patient and/or parent or legal guardian Travel costs at AA rates may be charged for travel from practice to theatre and return. 15

16 South African Optometric Association Tariffs st January 2002 Version 3.0 Fees inclusive of 14% V.A.T Series 5000 Ocular Prosthetics Existing Description Codes Prosthetic Consultation Impression for all Ocular prosthetics Iris Colour Model fitting Prosthesis Manufacture and Moulding Follow-up (within 6 months) Consultation away from Practice Glass Eye, complete with Consultation and Fitting Drill Ball and socket (pegging to Coral) Trimming and Re-shaping Build-up Veining Polishing Materials for Custom Eye Stock Eye Prosthetic Haptic Lens New Code Not yet approved by SAOA Motility/Coupling Peg Conforma Supply & Fit Conforma Supply Only Surcharge children under 5 years of age Assist in Theatre per 30 minutes Complete Eye 16