|Year : 2020 | Volume
| Issue : 4 | Page : 275-281
The effects of a novel preadapted ocular prosthesis on the quality of life of patients with anophthalmic contracted sockets
Amr M Awara, Osama E Shalaby
Department of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, Egypt
|Date of Submission||23-Mar-2020|
|Date of Decision||19-Apr-2020|
|Date of Acceptance||10-May-2020|
|Date of Web Publication||28-Dec-2020|
MD Amr M Awara
Department of Ophthalmology, Faculty of Medicine, Tanata University, El-Geish Street, Tanta 31511
Source of Support: None, Conflict of Interest: None
Purpose The aim of this study was to evaluate the effectiveness of a novel preadapted polymethyl methacrylate pressure prosthesis in patients with anophthalmic contracted sockets and its effect on their quality of life.
Patients and methods This is a controlled randomized clinical trial that included two groups of patients, with 19 patients in each. Group A received the new preadapted customized prosthesis fixed by periosteal sutures through custom-made holes during the primary reconstruction, whereas group B received the traditional transparent conformer for 6–20 weeks followed by the final cosmetic prosthesis. Prosthesis tolerability, socket inflammation, edema, contraction, and quality of life were assessed by the Medical Outcome Study short form-36 items.
Results Most of the patients (89.5%) in group A had a stable and well-centered prosthesis. Only two cases in this group had slightly shifted prosthesis without significant effect on the patient’s appearance. Group A had significantly shorter time (7.5±1.2 days) to return to their usual life activities and to uncover their prosthetic eye than group B (P<0.001). They also had significant improvement in the emotional health-related domains in the Medical Outcome Study short form-36 than group B. Complications in group A were minimal, as only one case had extrusion of the prosthesis owing to local infection.
Conclusion The preadapted polymethyl methacrylate pressure prosthesis with periosteal fixation is a simple and effective method in cases of severe anophthalmic socket contraction and resulted in early rehabilitation and improvement of patient’s quality of life.
Keywords: anophthalmos, contracted socket, preadapted ocular prosthesis, quality of life
|How to cite this article:|
Awara AM, Shalaby OE. The effects of a novel preadapted ocular prosthesis on the quality of life of patients with anophthalmic contracted sockets. Delta J Ophthalmol 2020;21:275-81
|How to cite this URL:|
Awara AM, Shalaby OE. The effects of a novel preadapted ocular prosthesis on the quality of life of patients with anophthalmic contracted sockets. Delta J Ophthalmol [serial online] 2020 [cited 2022 Jan 28];21:275-81. Available from: http://www.djo.eg.net/text.asp?2020/21/4/275/304937
| Introduction|| |
Anophthalmos is the clinical absence of the eyeball . Anophthalmic socket is turned into a contracted socket when it cannot support the prosthesis . In anophthalmic socket syndrome, fibrosis of the inferior fornix and shortage of the conjunctival tissue result in contraction, shallowness, or even obliteration of the socket. This contraction makes it very difficult for an implant to hold and function in an optimum way . These patients want to keep a normal look that even family and friends cannot feel abnormal about it ,. It is the role of the oculoplastic ophthalmic surgeon to restore the patient’s required normal look.
Most of the previous efforts were directed toward the reformation and widening of the fornices with placement of a conformer for variable periods of time ranging from weeks to months before the placement of the cosmetic shell. During this period of time, there is a big psychosocial burden on these patients, as they cannot resume their normal life until fitting of the permanent prosthesis that comes after weeks or months ,.
This study aimed to introduce a novel custom-made preadapted prosthesis that was fitted during the primary procedure of socket reconstruction. Thus, it can replace the period of ordinary conformer allowing early rehabilitation of the patient to resume his/her daily activities. The patients’ quality of life (QOL) after the prosthesis was also assessed.
| Patients and methods|| |
This is a prospective randomized controlled clinical study that included 38 contracted sockets of 38 patients admitted to the Oculoplasty Unit of the Ophthalmology Department, Tanta University Hospitals, Egypt.
The study was conducted from June 2015 to July 2018 and was approved by the Ethics Committee of the Faculty of Medicine, Tanta University and was done in accordance with the Declaration of Helsinki. All patients were interviewed before participating in the study, where all the procedures were fully explained to them. Patients aged 18 years or more with unilateral contracted socket were invited to participate in the study. All patients signed a written informed consent to participate in the study and for publication of data. A special consent was taken for the patients’ photographs (from those patients whose photographs were included in the manuscript).
Grading of contracted socket was based on Krishna grading . Patients with grades III and IV were included. Grade III was defined as loss of the upper, lower, medial, and lateral fornices, whereas grade IV was defined as loss of all fornices with reduction of the palpebral aperture in horizontal and vertical dimensions.
All steps were done under general anesthesia.
(a) Correction of surface and volume deficit:
Mucous membrane graft from oral mucosa was used to correct the mucosal deficit, whereas in severe empty contracted sockets, combined dermis-fat graft and mucous membrane graft were used to correct volume and surface deficit.
(b) Placement of the prosthesis:
After correction of surface and volume deficit, the patients were randomized equally into two groups, using a computerized random number generator to select randomly permuted blocks with a block size of four and an equal allocation ratio. Allocation concealment was done using sequentially numbered opaque sealed envelopes, which were opened after the patient signed the written consent and then enrolled into the respective group.
Group A included 19 sockets where the novel preadapted customized polymethyl methacrylate pressure prosthesis of the same color as the other eye was used. Four holes for fixation (two upper and two lower) and two lateral holes for drainage were drilled in the prosthesis. All holes were 0.5 mm in diameter and 1.5 mm away from the edge of the prosthesis, in most cases. The number of holes and their sites were customized for each case to overcome areas with severe contraction according to the clinical presentation. The holes were well centered to ensure equal suture tension from each side ([Figure 1]a and b). The edge of the prosthesis was a little bit sharp and slightly large to help widen the fornices. Double-armed nonabsorbable sutures of polypropylene 3/0 were passed from the prosthesis holes to the periosteum of the orbital rim and then toward the punctured skin openings. Sutures were then tightened, knotted, and buried under the skin ([Figure 2]a and b and [Figure 3]a–e). After 1 week, the prolene sutures were removed either from the upper or the lower edge, whereas the other edge was left sutured according to the configuration of preoperative contraction and degree of widening during surgery. This aims to flip the edge of the prosthesis to evaluate graft healing.
|Figure 1 (a) The customized prosthesis with the holes, and (b) placement and centration of the prosthesis.|
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|Figure 2 Suturing the customized prosthesis into a contracted socket. (A) Double armed polypropylene 3/0 were passed from the prosthesis holes to the periosteum of the orbital rim then towards the punctured skin openings (B) Both suture arms come out of the skin puncture.|
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|Figure 3 A female patient with (a) severely contracted socket. (b) Placement of the preadapted prosthesis showing three holes in the upper part with sutures running through them. (c) Tying and burial of the sutures. (d) The prosthesis in place. (e) The patient’s look 1 week after surgery.|
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Group B included 19 sockets in which the traditional transparent conformer was placed in the contracted socket for a variable period of time from 6 to 20 weeks, and then, the final prosthesis with the same color of the other eye was fitted. Postoperative treatment was topical antibiotic-steroid eye drops with systemic antibiotics and analgesics. This group acted as a control group.
Postoperative follow-up was done for 6 months by lifting the edge of the prosthesis to evaluate the presence of inflammation, infection, edema, anatomical reformation of fornices, or any lid malposition. In addition, patient tolerability, pain, and tenderness over the site of buried sutures were evaluated. In group A, the prosthesis was left in place as long as it was well tolerated and cosmetically accepted by the patient. By the end of the study, one patient was excluded from each group because they missed their regular follow-up visits.
Assessment of quality of life
The patient’s QOL was assessed by the Medical Outcome Study short form questionnaire (SF-36) items validated for Arabic. The patients were asked to fill in the SF-36 questionnaire 1 week before and after surgery. The questionnaire consists of eight domains reflecting different aspects of physical, emotional, social, and general health. The higher the score, the more favorable is the health status. The questionnaire is available at RAND health care (https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form.html).
Scoring the SF-36 Health Survey was done in a two-step process:
- Each numeric value for each question is recorded, which ranges from 0 to 100%.
- Items in the same domain are averaged to give the eight domain scores. Items that are left blank (missing data) were not taken into account when calculating the scale scores.
Data were tested for normality by Shapiro–Wilk’s test. Independent sample t test was used to test the difference between two readings of a normally distributed variable between two groups, whereas Mann–Whitney test was used for not normally distributed variables. For dependent variables (testing the same variable before and after intervention in the same group), paired t test was used for normally distributed variables and Wilcoxon test was used for not normally distributed ones. All analyses were done using SPSS, version 23 (SPSS Inc. Released 2015. IBM SPSS statistics for Windows, version 23.0; IBM Corp., Armonk, New York, USA).
| Results|| |
The mean age of the patients was 38.42±10.59 years. A total of 21 (55.3%) patients were males, 25 (65.8%) were manual workers, and 13 (34.2%) were employees. All patients had severely empty contracted sockets, with 26 (68.4%) patients being grade III and 12 (31.6%) patients being grade IV according to Krishna .
Overall, seven (18.4%) patients experienced postirradiation socket contraction, 22 (57.9%) patients had history of previous failed contracted socket repair, and 16 (42.1%) patients were naïve to treatment but all had empty socket at the time of the study.
The postoperative findings, in both groups, were similar. All patients had marked lid edema which resolved within 1 week postoperatively. In group A, 84.2% of the patients had stable and well-centered prosthesis during the whole period of follow-up ([Figure 3] and [Figure 4]). Only two (10.5%) patients experienced minor complications as the prosthesis was slightly shifted from the center, but this was accepted and did not bother the patients. One case showed pus coming out from the skin punctures 1 week postoperatively, which did not respond to medical treatment and necessitated removal of the prosthesis and sutures. No other complications were noted such as granuloma or tenderness.
|Figure 4 (a) A male patient with severe contracted socket preoperatively. (b) The same patient 1 week after surgery and placement of the newly customized prosthesis.|
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Patients in group A returned early to their usual life activities. They required 7.5±1.2 days to get back to work, which was significantly lower than in group B (13.8±4.30, P<0.001). They were also able to uncover their prosthetic eye and have almost normal social activities, whereas patients in group B could not.
Preoperatively, patients in both groups had severely low scores in the SF-36 domain concerned with the emotional health. They had a very low percentage of the ‘role limitation due to emotional problems, energy/fatigue, emotional well-being and social functioning domains,’ but the lowest was ‘role limitation due to emotional problems’ ([Table 1]).
|Table 1 Preoperative and postoperative Medical Outcome Study short form-36 questionnaire results|
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One week after surgery, both groups showed significant improvement in their QOL as indicated by the SF-36 questionnaire scores, including energy/fatigue, emotional well-being, social functioning, pain, and general health sections. However, patients in group A showed significantly marked improvement in the emotional health-related domains than patients in group B. The biggest improvement was in ‘the role limitation due to emotional problem,’ which improved from 2.10±0.78% preoperatively to 89.56±5.92% postoperatively ([Table 1]).
| Discussion|| |
Patients with anophthalmic sockets face daily challenges owing to the psychological burden caused by the absence of normal facial look that results in poor QOL .
Anophthalmic contracted socket is the major problem that prevents the surgeon from placing a prosthesis in the primary intervention. Instead, a plane conformer is placed to ensure maintenance of deep fornices, to be replaced later by the cosmetic shell prosthesis after 3–6 months. During this period of time, the patient is unable to face the community with uncovered eye .
The idea of replacing the conformer by a cosmetic shell prosthesis matched with the patient’s other eye, in the present study, is new and was not used before. This preadapted prosthesis can help the patient to resume his/her daily activities from day 1, postoperatively. Drilling holes near the edge of the prosthesis allowed the sutures to remain stable and to hold the prosthesis in the contracted socket. Early removal of sutures from one edge allowed evaluation of the graft under the prosthesis.
Most of the present techniques used to restore the depth of the lower fornix require long time before settling a prosthesis in the empty socket. This costs the patient a lot of psychic troubles, leads to delayed rehabilitation, and prevents them from the simple joy of normal daily life [10-14].
The reconstruction of the contracted socket is a real challenge for the ophthalmic plastic surgeon. In the present study, oral mucous membrane was used in 63% of the cases, whereas dermis-fat graft was used in 37% of the cases. Fornix deepening sutures were used in all cases.
Many methods have been used such as harvesting dermis-fat graft as done by Aryasit and Preechawai , with a success rate of 73.3 and with 22% failure. This was attributed to shrinkage of the mucous membrane, which occurred as a result of insufficient blood supply from the base. Ibrahiem and Abdelaziz  used fascia lata for their reconstruction, a technique that has limitation owing to difficulty in harvesting the fascia lata and its own complications. Baj et al.  tried different tissues to replace the lost tissue in different grades of contracted and anophthalmic sockets. They suggested that the best techniques are oral mucous membrane graft for moderately contracted sockets and dermis-fat grafts for empty contracted sockets. Bhattacharjee et al.  used porous polyethylene orbital ball implant with an overlying mucous membrane graft. Some patients experienced graft failure with recurrence of the contracture with fallout of the socket, ulceration, necrosis, and granuloma, causing slight misalignment, which required surgical correction.
All patients in previous studies had to wait at least 6 weeks before having the final prosthetic eye. Amornvit et al.  added the fabricated prosthesis after 3–4 months from using the pressure conformer.
For the sake of early patient rehabilitation, Eo et al.  studied the necessity of surgical rehabilitation for no implant anophthalmic sockets and the predictive factors for successful corrective procedure after secondary implant. Only five (26.3%) of their patients had satisfactory results with the secondary implant only, whereas 14 (74%) patients needed another surgical intervention for contacted socket complications like ptosis, shallow inferior orbits, or enophthalmos.
Patients, in the present study, had the chance to return rapidly to work after insertion of the prosthesis. They were able to fit again with their colleagues at work and their families at home without feeling shy or ugly.
Chin et al.  observed improvement of the QOL of their patients after replacement of a temporary ocular prosthesis at the time of removing the bandage (5 days after inserting a conformer).
The value and role of the current preadapted customized prosthesis include the following: (a) early rehabilitation of the patients because of the cosmetic appearance as it has the same color of the other eye; (b) fixation of the prosthesis to the periosteum, allowed it to work as a pressure conformer, producing continuous pressure on fornices to prevent its recontraction again; (c) gave the patient confidence that the prosthesis will not fall even if it started to extrude because it is fixed to the periosteum; and (d) lower rates of recontraction during the short-term follow-up (9 months).
| Conclusion|| |
To conclude, the present custom-made preadapted pressure prosthesis with periosteal fixation allowed early rehabilitation of the patients with maintenance of deep fornices and less recontraction especially in severely contracted sockets. Short-term follow-up of the patients showed complete satisfaction and highly improved QOL.
| Acknowledgements|| |
This work was self-funded by the authors.
Part of this work was presented at ESOPRS 2018 in Bucharest.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]