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Cervical range of motion test-retest results in 20 patients testedby examiner 1 (A) and examiner 2 (B).

Cervical range of motion test-retest results in 20 patients testedby examiner 1 (A) and examiner 2 (B).

1.
Urist  M A lateral version light-reflex test. Am J Ophthalmol. 1967;63808- 815
PubMed
2.
Woodruff  GO'Reilly  CKraft  S Functional scoring of the field of binocular single vision in patientswith diplopia. Ophthalmology. 1987;941554- 1561
PubMedArticle
3.
Holmes  JMHochberger  GGLeske  DA Photographic and clinical techniques for outcome assessment in sixthnerve palsy. Ophthalmology. 2001;1081300- 1307
PubMedArticle
4.
Scott  ABKraft  SP Botulinum toxin injection in the management of lateral rectus paresis. Ophthalmology. 1985;92676- 683
PubMedArticle
5.
Kestenbaum  A Clinical Methods of Neuro-ophthalmological Examinations. 2nd New York, NY Grune & Stratton1961;237- 239
6.
Kushner  B The usefulness of the cervical range of motion device in the ocularmotility examination. Arch Ophthalmol. 2000;118946- 950
PubMed
Clinical Sciences
March 2004

Comparing Ocular Muscle Limitation Tests for Clinical Trial Use

Author Affiliations

From the Institute for Neurology and Neurosurgery at Beth Israel MedicalCenter and New York Eye and Ear Infirmary, New York (Dr Kupersmith); and Departmentof Ophthalmology, University of Vermont School of Medicine, Burlington (DrFazzone). The authors have no relevant financial interest in this article.

Arch Ophthalmol. 2004;122(3):347-348. doi:10.1001/archopht.122.3.347
Abstract

Objective  To evaluate portable methods for documenting ocular muscle limitationthat might be used at multiple sites in a clinical trial.

Methods  In a prospective consecutive case series, 2 examiners independentlyevaluated 3 methods of ocular muscle duction testing: a grading scale of 0to −5 that is in clinical use, the Kestenbaum limbus test using a rulerto measure the millimeters of ocular movement, and an adapted cervical rangeof motion (CROM) device that measures ocular movement in degrees. Twenty consentingpatients (mean age, 55 years) with diplopia, 8 with ocular myasthenia gravis,11 with a cranial nerve III or VI palsy, and 1 with dysthyroid ophthalmopathywere studied.

Results  For Kestenbaum measures, between examiners the standard deviation ofthe difference for all ductions was 1.9 mm (r = 0.75, P = .01); 95% of differences were 4 mm or less. For theCROM device, the standard deviation of the difference was 7.1°; 95% ofdifferences were 15° or less (r = 0.73, P = .01). For each examiner, the CROM standard deviationof the difference was less than 2° (r = 0.98, P = .01). For the grading scale, the 2 examiners had thesame score in 85% of ductions (r = 0.92, P = .01).

Conclusions  The Kestenbaum test and the CROM device gave similar interexaminer repeatability.The repeatability for CROM measures for each examiner was high but was considerablyless between examiners. The grading scale gave similar results between examiners.

Standardized objective testing is needed to gauge the effect of therapyon ocular motor dysfunction, but specific methods have not been used in aclinical trial. The technique of Urist,1 binocularfield testing,2 and Hess screen are not suitablebecause of low retest reliability, poor correlation with the patient's visualdisability, and the need for a stable area of binocular single vision, whichis often absent in a variable disorder such as myasthenia gravis. A photographicsystem used in the assessment of sixth nerve paresis, although reliable andreproducible, is not portable.3 We assessed3 methods that are fast, portable, and readily available and might providemeasurements of ocular muscle limitation in a clinical trial.

METHODS

We tested supraduction, infraduction, abduction, and adduction of eacheye monocularly by 3 methods: a grading scale4 with0 for full excursion and −5 for failure to reach the midline (−4reaching midline, −3 to −1 for excursions in 25% increments);millimeters of excursion by means of the limbus test5;and the degrees of movement measured with an adapted cervical range of motion(CROM) device.6 Wearing the CROM device, aheadgear and spectacle frame with gravity-driven meters, the patient fixatedon a 20/40 letter as the examiner rotated the patient's head. When the patientnoted optotype blur caused by rotation of the head moving the target off themacula, we recorded the degrees registered on the appropriate meter. EachCROM measure was repeated.

Two examiners independently prospectively tested 20 patients with diplopiacaused by unilateral cranial nerve III or VI palsy (11 patients), dysthyroidophthalmopathy (1 patient), and myasthenia gravis (8 patients) (mean age,55 years). All patients gave informed consent. The repeatability of CROM measuresfor each examiner and the standard deviation of the difference for all resultsbetween examiners were evaluated by means of Pearson correlation or intraclasscorrelation coefficient.

RESULTS

For the limbus test results, the standard deviation of the differencefor 160 ductions between examiners was 1.9 mm (r =0.75, P = .01); approximately 95% of differenceswere 4 mm or less.

For CROM measures between examiners, the standard deviation of the differencewas 7.1°; approximately 95% of differences were 15° or less (r = 0.73, P = .01). For each examiner,the standard deviation of the difference for the repeated CROM measurementswas less than 2° for each examiner (r = 0.98, P = .01) (Figure 1).

For the grading scale, the 160 ductions for each examiner were the samegrade in 85% (r = 0.92, P =.01). The grades differed by 1 grade in 25 measures and by 2 grades in 1 measure.

COMMENT

Our results with the CROM device gave a standard deviation of the differencebetween examiners considerably larger than the 1.1° reported by Kushner.6 The variability of the results for 2 examiners suggeststhat neither the limbus test nor the CROM device method as performed in thisstudy is suitable for a clinical trial. In addition, ptosis, poor vision,and bifocal and progressive glasses limit the use of the CROM device. Althoughthe categorical grading system results were consistent between examiners,the coarse determinations may not disclose all clinically relevant changesin a multicenter study. We remain unconvinced that any of these or other existingmethods for assessing extraocular muscle limitation or binocular diplopiacan be used to determine the effects of therapy, particularly in general ophthalmologyor neurology clinics.

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Article Information

Corresponding author: Mark J. Kupersmith, MD, INN at Beth IsraelNorth, 170 East End Ave, New York, NY 10128 (e-mail: mkuper@bethisraelny.org).

Submitted for publication June 12, 2003; final revision received October9, 2003; accepted November 3, 2003.

This study was supported by the Michael Fischer Foundation, Miami, Fla.

References
1.
Urist  M A lateral version light-reflex test. Am J Ophthalmol. 1967;63808- 815
PubMed
2.
Woodruff  GO'Reilly  CKraft  S Functional scoring of the field of binocular single vision in patientswith diplopia. Ophthalmology. 1987;941554- 1561
PubMedArticle
3.
Holmes  JMHochberger  GGLeske  DA Photographic and clinical techniques for outcome assessment in sixthnerve palsy. Ophthalmology. 2001;1081300- 1307
PubMedArticle
4.
Scott  ABKraft  SP Botulinum toxin injection in the management of lateral rectus paresis. Ophthalmology. 1985;92676- 683
PubMedArticle
5.
Kestenbaum  A Clinical Methods of Neuro-ophthalmological Examinations. 2nd New York, NY Grune & Stratton1961;237- 239
6.
Kushner  B The usefulness of the cervical range of motion device in the ocularmotility examination. Arch Ophthalmol. 2000;118946- 950
PubMed
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