Miotics and retinal detachment: Upgrading the community standard

SURVEY OF OPHTHALMOLOGY

VOLUME 35 - NUMBER 4 * JANUARY-FEBRUARY 1991

MEDICOLEGALITIES,

JEROME BElTMAN,

EDITOR

Miotics and Retinal Detachment: Upgrading the Community Standard MARVIN F. KRAUSHAR,

M.D.,’ AND JAMES A. STEINBERG,

‘Westfield,

New Jersey,

and ‘Poughkeepsie,

L.L.B.2

New York

The majority of ophthalmologists who responded to a questionnaire regarding the relationship between miotics and retinal detachment felt that such a relationship does exist, and

Abstract.

that myopia and aphakia/pseudophakia predispose to the formation of new retina1 breaks or to retinal detachment from pre-existing breaks with miotics. Horseshoe breaks and dialyses are pre-existing lesions that should be treated prophylactically prior to miotic therapy. Patients with no predisposing pathology or whose eyes have lattice degeneration or operculated breaks should be warned of possible retina1 detachment prior to starting miotics. Not performing a peripheral retina examination prior to prescribing a miotic is acceptable, but not optimal, medical practice. Examining the peripheral retina or obtaining a retina consultation prior to prescribing a miotic may be beneficial to the patient and could be invaluable in the defense of litigation. Surv Ophthalmol 35:311-316, 1991)

Key words.

miotics

l

retinal detachment

One of us (MFK) reviewed a malpractice claim wherein the patient developed a retinal detachment after using 3% carbachol for twelve days for chronic open angle glaucoma. The patient was an 11D myope who was treated initially with a beta blocker with insufficient. reduction of intraocular pressure. Pilocarpine 2% was added to the regimen, but the patient complained of headache and sweating after two days and carbachol was substituted for the pilocarpine. The ophthalmologist had not done a peripheral retina examination prior to starting the pilocarpine. There was no discussion of the risk of retinal tears or detachment and the patient was not warned to return if he noted flashes and/or floaters. The patient called the ophthalmologist the first day he noted floaters. A retinal detachment was diagnosed, and he was referred to a retina surgeon. The retina surgeon found three areas of lattice degeneration with round atrophic holes in each eye and a retinal detachment in the symptomatic eye. Successful scleral buckle surgery and cryoretinopexy of the fellow eye were performed the next day.

The patient alleged the ophthalmologist had been negligent in failing to diagnose the lattice degeneration prior to the use of miotics, thus depriving him of the chance for prophylactic therapy, which might have prevented the retinal detachment. Conversations with general ophthalmologists in the community revealed that it was not the practice of the majority of those questioned to do a peripheral retina examination routinely or prior to prescribing miotics. This fact, if established, can provide a basis for the potential successful defense of the ophthalmologist. In such a circumstance the community standard - not performing a peripheral retina examination prior to the use of miotics has not been breached. The law does not expect the involved physician to be the best physician possible. He is, however, expected to perform as would any physician of ordinary skill, care, and diligence in his specialty. This is the concept ofthe community standard. In order to find a defendant physician liable for damages it must be proven that “the defendant did (or failed to do) some particular thing or things 31 1

312

Surv Ophthalmol

35 (4) January-February

1991

that physicians of ordinary skill, care and diligence, practicing at the same time, in the general area and in the same specialty would not have done (or failed to do) under the same or similar circumstances.“’ I therefore undertook to determine the community standard regarding retinal examination and the prescription of miotics throughout the United States. The presence or absence of a relationship between miotics and retinal detachment can best be determined only by a large prospective study with matched controls. Such an undertaking is beyond the scope of this paper. It is our aim only to define the community standard by which ophthalmologists in the United States are managing patients using miotics and to offer suggestions that may improve the standard of care.

Distribution of the Questionnaire Questionnaires were distributed to 500 attendees of a general ophthalmologist symposium at a meeting of the American Society for Contemporary Ophthalmology. Questionnaires were mailed to the 187 members of the Retina Society actively practicing in the United States. Also surveyed by mail were the 46 members of the American Glaucoma Society. Responses were anonymous unless individuals voluntarily signed their names. Answers such as “probably,” “maybe,” or “perhaps” were classified as uncertain. Respondents were requested to comment wherever they felt it appropriate.

Responses Questionnaires were completed by 430 (86%) of the general ophthalmologists, 101 (54%) of the retina specialists, and 30 (65%) of the glaucoma specialists. The results are presented in Table 1. The probability exists that the generalist/sub-specialist orientation of respondents affected their answers. Since the population sizes of the three subgroups do not represent a proportion consistent with actual percentages of practicing generalists or subspecialists the data are not cumulated in a separate column. The majority of responses by all three groups to question 1 suggests a relationship between retinal detachment and the use of miotics. The retina specialists were the most skeptical. Three retina specialists (3%) and three glaucoma specialists (7%) recalled patients of their own in whom a retinal detachment occurred long after starting miotics and concluded there is no such relationship. Two retina specialists (2%) cited the 2% incidence of chronic open angle glaucoma in patients over the age of forty and the 7% prevalence of lattice degeneration in the general population and concluded

KIWUSHAR

AND STEINBERG

that there was, thus, only a chance association between miotics and retinal detachment in these patients. Ten general ophthalmologists (2%), seven retina specialists (7%) and four glaucoma specialists (13%) mentioned that stronger miotics were more likely to cause a retinal detachment. Three retina specialists (3%) cautioned against miotic reversal of routine diagnostic pharmacologic mydriasis. Answers to question 2 show agreement that there are high risk refractive states which predispose to the development of new retinal breaks or to retinal detachment from pre-existing breaks with miotics. Those eyes presumed at greatest risk are myopic (high myopia does not confer even greater risk) or aphakic/pseudophakic. No comments were volunteered as to whether eyes with intracapsular surgery with anterior chamber implants were at greater risk than eyes with extracapsular surgery and posterior chamber implants. A second part of question 2 asked, “What do you consider high myopia?” The average estimate of high myopia by general ophthalmologists was 5.1 D or greater with a range of 2 - IOD, a median and a mode of 5.OD. Retina specialists defined high myopia as an average of 6.3D or greater with a range of 3 - lOD, a median and mode of 6.OD. The average estimate of high myopia by glaucoma specialists was 5.6D or greater with a range of 3 - IOD. The median was 5.OD and the mode was 3.OD. No respondent commented on whether the degree of myopia was to be determined by spectacle refraction or measurement of axial length. Responses to question 3 indicate agreement that certain pre-existing retinal lesions predispose to retinal detachment with miotics. The most significant of these are horseshoe retinal breaks and dialyses. Six retina specialists (6%) suggested that lattice degeneration with small degenerative holes is more serious than lattice without holes. Five glaucoma specialists (17%) felt that only those eyes which are predisposed to retinal detachment in the general population are at risk with miotics. The low number of “none” and “uncertain” responses indicate over 90% of general ophthalmologists and retina specialists and 60% of glaucoma specialists would want prophylactic therapy if their eyes were at risk and they were about to begin miotic therapy. In response to question 4, no general ophthalmologist, only three retina specialists, and one glaucoma specialist would manage a patient whose eye was at risk by simply prescribing a miotic. If predisposing retinal lesions were found, general ophthalmologists and retina specialists were relatively evenly divided between prescribing miotics with a warning regarding symptoms of possible retinal tear or detachment and advising prophylactic treat-

MIOTICS

AND

RETINAL

DETACHMENT

313 TABLE Questionnaire

1

and Responses Responses

Choices

Question 1. Is there an association retinal detachment use of miotics?

General Ophth. (n=430)

between and the

Retina Spec. (n= 101)

(al) Glaucoma Spec. (n=JO)

Yes No Uncertain

77.0 2.3 20.7

58.4 10.0 31.6

73.3 3.3 23.3

2. Which refractive status predisposes to new breaks or to retinal detachment from pre-existing breaks with miotics?

Aphakialpseudophakia Myopia High myopia None Uncertain

67.6 41.8 42.0 3.9 10.2

41.5 30.6 32.7 14.8 16.8

50.0 33.3 36.6 3.3 13.3

3. If your eyes had one of the following lesions would you want prophylactic treatment prior to using miotics?

Horseshoe break Dialysis Lattice degeneration Operculated break None Uncertain

91.3 62.7 48.8 44.2 2.0 2. 5

83.1 57.4 36.6 40.5 8.9 0.9

53.3 53.3 16.7 30.0 30.0

0.0 34.9 42.3 22.8

3.0 45.5 32.7 17.8

3.3 40.0 6.7 50.0

10.0

4. If a general ophthalmologist has done a peripheral retina exam and predisposing pathology is found, should he/she:

Rx miotic Rx miotic & warn Advise prophylactic Other

5. If a general ophthalmologist has done a peripheral retina exam and no predisposing pathology is found, should he/she:

Rx miotic Rx miotic & warn of possible RD Recommend a retina consultation Other

14.4 82.1 2.6 0.9

24.7 72.3 2.0 0.0

50.0 50.0 0.0 0.0

6. If a general ophthalmologist has not done a peripheral retina exam and prescribes a miotic, is this:

Appropriate Acceptable Negligent Uncertain

14.0 45.8 33.0 7.2

4.9 68.3 22.8 3.0

23.3 46.7 23.3 6.7

ment. Glaucoma specialists were closely divided between prescribing a miotic with an appropriate warning or using alternative glaucoma therapy. Two glaucoma specialists (7%) were hesitant to advise prophylaxis. Two retina specialists (2%) and one glaucoma specialist (3%), all of whom felt there was no relationship between miotics and retinal detachment, recommended prophylactic treatment, because if suspicious symptoms occurred after prolonged miotic therapy it might be difficult or impossible to adequately examine and/or treat the peripheral retina. Although the specific choice of a retina consultation was not provided, this option was volunteered by 78 general ophthalmologists (18%), 18 retina specialists (18%) and 14 glaucoma specialists (47%). Twenty general ophthalmologists (5%), one retina specialist (1%) and one glaucoma specialist (3%) who answered “other” suggested using non-miotics, such as a beta blocker or epinephrine. Responses to question 5 suggest a majority of

of possible treatment

but not optimal

RD

general ophthalmologists (82%) and retina specialists (72%) and half the glaucoma specialists were confident in the ability of the general ophthalmologist to examine the peripheral retina; thus, they recommended miotic therapy with appropriate warnings to the patient rather than a retina consultation if no predisposing pathology were found. Four general ophthalmologists (1%) suggested using therapy other than a miotic. Approximately 60-70% of respondents to question 6 in each group indicated it is not negligent to prescribe miotics without examining the peripheral retina. A greater percentage of retina specialists thought this was not optimal medical practice. Approximately 23-33% of all respondents felt this breached the acceptable standard of care and was, thus, negligent. Twenty general ophthalmologists (5%), ten retina specialists (10%) and two glaucoma specialists (7%) felt peripheral retina examination should be part of a routine eye examination. One glaucoma specialist (3%) felt peripheral retina ex-

314

Surv Ophthalmol

amination

35 (4) January-February

should be routine

1991

in high risk eyes.

Comment There has been continuing controversy regarding the relationship of miotics to retinal detachment for approximately 50 years. Becker’ demonstrated how frequently retinal detachment and glaucoma are associated when he reported glaucoma in 12.3% of 530 patients with detached retina. Other series reported incidences of 4%, 4%, 12%, and 9%.6X10,‘5.‘R No conclusive cause-and-effect relationship has ever been established or agreed upon. Some authors4s5 have denied any causative role for miotics. Others2,‘2,‘5 have suggested that certain eyes might be predisposed to retinal detachment during miotic therapy. Those predisposing factors mentioned include peripheral retinal degeneration or thinning, lattice degeneration, retinal tears, previous retinal detachment, myopia, high myopia and aphakia. Page and ForbesI reported 34 eyes of 31 of their patients who developed retinal detachment while on miotic therapy. Twenty-seven eyes (79%) had one or more predisposing factors (myopia, aphakia or lattice degeneration). The degree of myopia was determined from the spectacle refraction and was, therefore, not necessarily axial myopia. The range was 0.25 to 15.00 diopters with an average of 4.39 diopters. One of us (MFK) has found in the literature’ and in his own practice several patients who developed retinal detachment following an idiosyncratic reaction to miotics. The symptoms have included paresthesia, nausea, sweating and anxiety. Such a reaction probably occurred in the patient reported in this article. Weak and strong miotics have been implicated in the literature. These include pilocarpine, eserine, carbachol, mintachol, humorsol, isofluorophate (DFP) and phospholine iodide. It has been suggested that stronger miotics have a greater tendency to produce retinal detachmentI The fact that pilocarpine is associated with the greatest number of reported cases may be explained by its more extensive use. Page and ForbesI reviewed ten studies in the literature involving 36 eyes with retinal detachment in patients using miotics. The duration of miotic therapy prior to onset of symptoms of retinal detachment ranged from ten hours to sixty days. Of the authors’ own 31 patients (34 eyes) 14 eyes (41%) developed symptoms within two months of miotic therapy and 22 eyes (65%) within a year. Kraushar and Podell’ found an average of 23 days between miotic therapy and onset of symptoms in their patient and in 2 1 patients in the literature. They also found that 64% of patients in the literature studies had already been on miotic therapy and developed retinal detachment within an average of 23 days

RRAUSHAR

AND STEINBERG

after being switched to a stronger miotic. This also occurred in the patient reported in this article. Lemcke and Pischel13 concluded that since no cases of new retinal dialysis have been reported, the mechanism of miotic-induced retinal detachment was vitreous traction secondary to the action of miotics. MosesI suggested intense ciliary muscle spasm might be followed by peripheral retinal breaks. Another possible mechanismI is forward movement of the choroid and overlying ora serrata, causing forward displacement of the ciliary body. suggested that hypotony following Ackerman” miotics may lead to retinal detachment in eyes with pre-existing retinal breaks. Miotic therapy may in some way weaken the adhesion between the retinal pigment epithelium and the photoreceptors.“j Many authors recommend peripheral retina examination prior to the use of miotics, but only a few15J7 recommend prophylactic treatment of retinal breaks. It was not the aim of this study to prove or disprove any particular fact or theory, but only to determine the consensus of the ophthalmic community with respect to the standard of care of patients being treated for glaucoma with miotics. It should be kept in mind that most, if not all, of the following discussion represents opinions and not necessarily medical facts. The majority believes there is an association between the use of miotics and retinal detachment. The association may be greater with the use of stronger miotics. Patients using a miotic for a short or long period may also be at risk if they are switched to a stronger miotic. It may be advisable not to use a miotic to reverse routine diagnostic pharmacologic mydriasis in high risk patients. Myopia predisposes to the development of new retinal breaks or to retinal detachment from preexisting breaks with miotics but high myopia does not necessarily confer even greater risk. Also at risk are aphakic and pseudophakic eyes. Eyes with pre-existing retinal lesions which put them at risk for retinal detachment with miotics are candidates for prophylactic treatment. These eyes are commonly considered at risk for retinal detachment in the general population. These include aphakic or pseudophakic eyes with any type of break and phakic eyes with horseshoe breaks or dialyses. Furthermore, if symptoms of possible retinal tear or detachment occur after prolonged miotic therapy, it may not be possible to adequately examine and/or treat the peripheral retina. A history of previous retinal detachment does not predispose to retinal detachment with miotics.‘5,‘7 If lattice degeneration or an operculated break is found in a phakic eye, it is appropriate to prescribe a miotic and warn the patient regarding the ap-

MIOTICS

AND RETINAL

DETACHMENT

pearance of flashes and/or floaters. Since the majority of retina specialists would not have these lesions treated in their own eyes, failure to examine the retina or failure to diagnose the break on peripheral retina examination is arguably not negligent management which was the proximate cause of any injury sustained by the patient. In a medicolegal setting, a judge or jury could find a deviation from proper care (malpractice), but still find in favor of the physicianldefendant on the basis that no injury was proximately caused by the deviation from proper care. A significant minority of all three groups suggests prophylactic therapy or obtaining of a retina consultation. Conversations with general ophthalmologists have indicated that referral for a consultation would involve less than a half-dozen patients yearly for the average general ophthalmic practitioner. An alternative is a form of therapy other than a miotic. If no predisposing pathology is found, it is appropriate to prescribe a miotic, discuss the possible relationship of miotics and retinal detachment, and warn the patient of suspicious symptoms. Failure to do so, in the context of a malpractice suit, could result in a verdict against the physician on the grounds of failing to obtain an informed consent.’ Not performing a peripheral retina examination prior to prescribing miotic therapy, especially for patients at risk, is acceptable according to approximately Vr of the respondents, but it is not optimal medical practice. For at least the most recent three decades, resident training programs have provided ample opportunity and instruction to attain proficiency at examining the peripheral retina. This experience was thus available to practically every ophthalmologist currently practicing in the United States. It would not be unduly burdensome for the ophthalmologist, and it would upgrade the quality of medical care to use this modality or to request a retina consultation for at least the small aggregate of patients beginning miotic therapy or being switched to a stronger miotic regardless of whether they may appear to be at risk. The verdict of ajury in medical malpractice litigation is based upon the preponderance of evidence (at least 51%)) as opposed to “beyond a reasonable doubt,” as in a criminal trial. Despite the common belief that no cause-and-effect relationship between miotics and retinal detachment has ever been proved, there are ophthalmologists who will be willing to testify in good conscience that within reasonable medical probability there is strong evidence that such a relationship does in fact exist. A review of questionnaire responses indicates that a significant minority of ophthalmologists feels it is negligent to prescribe miotics without examining the pe-

315 ripheral retina (questions 1 8c 6). Furthermore, the majority of ophthalmologists would want certain pre-existing pathology in their own eyes treated prophylactically (question 3). This is difficult to reconcile with responses to question 6, wherein 60-70% of respondents feel it is not negligent to prescribe miotics without examining the peripheral retina. To expect that a jury would accept a lesser standard of care for a non-ophthalmologist-patient is unrealistic. Beyond that, the reason the lawsuit will exist in the first place is because a retinal detachment occurred during miotic therapy. Juries are not enamored of the “coincidence” defense and may well be partial to the plaintiffs theory regarding causation. It therefore stands to reason that performing a peripheral retina examination or obtaining a retina consultation prior to prescribing miotics would be strongly supportive to an ophthalmologist in the event of litigation.

Editorial

Comment

Dr. Kraushar and Mr. Steinberg attempt to provide answers to several questions. Do miotics cause a retinal detachment in a predisposed eye? Should miotics be withheld in certain eyes and if so which? IS it necessary to examine the periphery of the retina before starting miotic therapy and who is competent to do the examination? It has not been proven that miotic therapy can cause retinal detachment although there is some rather convincing anecdotal evidence. The incidence of retinal detachment in patients on miotic therapy is extremely low. There is no proof that examination of the peripheral retina prior to starting miotic therapy is of any greater value than routine examination of the peripheral retina in any patient. Despite the absence of such proof, many ophthalmologists believe that if a patient were found to have some type of threatening lesion in the peripheral retina, the patient would be better served by either withholding miotic therapy or treating the lesion before prescribing the miotic agent. One of us (MF) routinely examines the peripheral retina by indirect ophthalmoscopy in all glaucoma patients with conditions that might predispose to retinal detachment (high myopia, pigmentary glaucoma, aphakia, family history of retinal detachment, light flashes etc.). The examination is especially thorough prior to use of a miotic agent. Retinal consultation is requested in the event of a positive finding such as hole or lattice degeneration. In the majority of glaucoma patients not predisposed to retinal detachment, the peripheral retina is examined by direct ophthalmoscopy after

316

Surv Ophthalmol 35 (4) January-February

1991

pupillary dilation. In eyes with primary angle-closure glaucoma that are not predisposed to retinal detachment, miotic therapy is used without diagnostic pupillary dilation until a laser iridotomy has been performed. The authors do not attempt to provide a scientific proof of any statements but present statistics regarding the opinions of ophthalmologists. This is significant in relation to the establishment of acceptable standards of practice or, conversely, what may or may not be substandard practice i.e. malpractice. Physicians are held to the community standard, with the unusual exception of a court imposed standard. It is not necessary to do what a majority of physicians would do to comply with the community standard but only what a minority of acceptable physicians would do under the same circumstances. JEROME MAX

BERMAN,

FORBES,

M.D.,

M.D.,

EDITOR

CONSULTANT

ICRAUSHAR AND STEINBERG

9. 10.

11.

12.

13. 14. 15. 16.

References Ackerman AL: Retinal detachment and miotic therapy, in Pruett RL, Regan CDJ (eds): Retina Congress. New York, Appleton-Century-Crofts, 1972, pp 533-539 Beasley H, Fraunfelder F: Retinal detachments and topical miotics. Ophthalmology 86:95-98, 1979 Becker B, in discussion, Smith JL: Retinal detachment and glaucoma. Trans Am Acad Ophthalmol Otolaryngol67:73 l-732, 1963 Freilich DB, Seelenfreund MH: Miotic drugs, glaucoma and retinal detachment. Mod Probl Ophthalmol15:318-322, 1975

17. 18.

Havener W: Ocular Pharmucology. St Louis, CV Mosby, ed. 3, 1974, p 295 Guillaumat 1, Bonnin P: Decollement de la retine et hypertonie. Mod Probl Ophthalmol 98: 113, 1967 Hickman v. Employer’s Fire Insurance Company, 1975,3 11 So.2d:778 Kraushar MF, Podell DL: “Miotic-induced” retinal detachment, in Pruett RL, Regen CDJ (eds): Retina Congress. New York, Appleton-Century-Crofts, 1972, pp 54 l-545 Kraushar MF, Steinberg JA: Informed consent: surrender or salvation? Arch Ophthulmal 1986;104:352-355 Langham ME, Regan CDJ: Circulatory changes associated with onset of primary retinal detachment. Arch Ophthalmol 86:820-829, 1969 Lemcke H, Pischel DK: Retinal detachments after the use of ohosnhohne iodide. Trans Pat Coast Otoobhthalmol Sot 47: i57-i63, 1966 Leopold IH, McDonald PR: Di-isopropyl fluorophosphate (DFP) in the treatment of glaucoma. Arch Ophthalmol 40: 176-188, 1948 Moses R: in Adler FH (ed): Physiology of the Eye. St Louis, CV Mosby, ed 6, 1974, p 205 Page LG, Forbes M: Retinal detachment and miotic therapy. Am J Ophthalmol 85:558-566, 1978 Phelps CD, Burton TC: Glaucoma and retinal detachment. Arch Ophthalmol 95.418-422, 1977 Schepens CL, in discussion, Ackerman AL: Retinal detachment and miotic therapy, in Pruett RL, Regan CDJ (eds): Retina Congress. New York, Appleton-Century-Crofts, 1972, p 539 Schepens CL: Retinal Detachment and Allied Diseases, Vol 1. Philadelphia, WB Saunders, 1983, pp 63-64 Syrdalen P: Trauma and retinal detachment: The anterior chamber angle, with special reference to width, pigmentation and traumatic ruptures. Acta Ophthalmol48:1006-1023, 1970

Reprint address: Marvin F. Kraushar, nue West, Westfield, N.J. 07090.

M.D., 600 South

Ave-