Comparison of the Effect of Atropine and …art45-paediatric-studies-docs.ema.europa.eu/GROUP...

4
180 Ann OphthalmoI1989;21:180-187 Comparison of the Effect of Atropine and Cyciopentoiate on Myopia MAY-YUNG YEN, MD, JORN-HoN Lru, MD, SUI-CHING KAO, MD, AND CHUNG- Ho SHIAO, MD We evaluated the effectiveness of cycloplegics in the treatment of myopia. Patients were se- lected randomly and divided into three groups: Group 1 received atropine 1 % eye drops every other night; Group 2 received cy- clopentolate 1 % eye drops every night; and Group 3 received normal saline eye drops ev- ery night. All the patients were rechecked ev- ery three months. The results were evaluated at the end of one year. Ninety-six patients were evaluated, 32 in each group. The mean myopic progression was -0.219 D in the atropine group, -0.578D in the cy- clopentolate group, and -0.914D in the sa- line group. Analysis showed that atropine and cyclopentolate are effective in slowing the progression of myopia. The effect of atropine is better than that of cyclopentolate. T here is an association between an in- creased prevalence of myopia with higher degrees and intensity of schooling. The inci- dence of myopia increases from 5% to 10% to 35% to 45% from first grade to sixth grade, causing a severe social problem in Taiwan. Several statistical studies have addressed the subject of close work as a cause of myopia. 1 ,2 Since Bedrossian's3 study in 1964, interest in the treatment of progressive myopia with cycloplegic drugs in children has been rekin- dled. We did a prospective study of treatment of progressive myopia with atropine 1 %, cy- clopentolate 1 %, and normal saline. Patients and Methods From July 1, 1985 to October 31, 1986,247 children with simple myopia were selected randomly from the patients in our Refraction Clinic. There were 1 18 boys and 129 girls. The age distribution was from six to 14 years old (average age, 9). The refraction error was from -0.5D to -4.0D. Patients with a tropia, amblyopia, or a cylinder refraction greater than 1 D were excluded. All children had a complete ophthalmo- logic examination, including vision, cyclople- gic refraction, keratometry, axial length, fun- duscopy, and intraocular pressure examina- tion. The cycloplegic refraction was done with two drops of cyclopentolate 1 % and two drops of tropic amide 1 %, separated by a five-minute interval. Refraction was done 30 minutes later. All 247 children were divided randomly into three groups. The first group received at- From the Department of Ophthalmology, Veterans General Hospital, Yang-Ming Medical College, Taipei, Taiwan, Re- public of China. Address for reprints: M.Y. Yen, MD, Department of Ophthalmology, Veterans General Hospital, Taipei, Taiwan, ROC, 112.

Transcript of Comparison of the Effect of Atropine and …art45-paediatric-studies-docs.ema.europa.eu/GROUP...

Page 1: Comparison of the Effect of Atropine and …art45-paediatric-studies-docs.ema.europa.eu/GROUP C/Cyclopentolate...Comparison of the Effect of Atropine and Cyciopentoiate on Myopia MAY-YUNG

180 Ann OphthalmoI1989;21:180-187

Comparison of the Effect of Atropine and Cyciopentoiate on Myopia

MAY-YUNG YEN, MD, JORN-HoN Lru, MD, SUI-CHING KAO, MD, AND CHUNG-Ho SHIAO, MD

We evaluated the effectiveness of cycloplegics in the treatment of myopia. Patients were se­lected randomly and divided into three groups: Group 1 received atropine 1 % eye drops every other night; Group 2 received cy­clopentolate 1 % eye drops every night; and Group 3 received normal saline eye drops ev­ery night. All the patients were rechecked ev­ery three months. The results were evaluated at the end of one year. Ninety-six patients were evaluated, 32 in each group.

The mean myopic progression was -0.219 D in the atropine group, -0.578D in the cy­clopentolate group, and -0.914D in the sa­line group. Analysis showed that atropine and cyclopentolate are effective in slowing the progression of myopia. The effect of atropine is better than that of cyclopentolate.

There is an association between an in­creased prevalence of myopia with higher

degrees and intensity of schooling. The inci­dence of myopia increases from 5% to 10% to 35% to 45% from first grade to sixth grade, causing a severe social problem in Taiwan. Several statistical studies have addressed the subject of close work as a cause of myopia.1,2

Since Bedrossian's3 study in 1964, interest in the treatment of progressive myopia with cycloplegic drugs in children has been rekin­dled. We did a prospective study of treatment of progressive myopia with atropine 1 %, cy-

clopentolate 1 %, and normal saline.

Patients and Methods

From July 1, 1985 to October 31, 1986,247 children with simple myopia were selected randomly from the patients in our Refraction Clinic. There were 1 18 boys and 129 girls. The age distribution was from six to 14 years old (average age, 9). The refraction error was from -0.5D to -4.0D. Patients with a tropia, amblyopia, or a cylinder refraction greater than 1 D were excluded.

All children had a complete ophthalmo­logic examination, including vision, cyclople­gic refraction, keratometry, axial length, fun­duscopy, and intraocular pressure examina­tion. The cycloplegic refraction was done with two drops of cyclopentolate 1 % and two drops of tropic amide 1 %, separated by a five-minute interval. Refraction was done 30 minutes later.

All 247 children were divided randomly into three groups. The first group received at-

From the Department of Ophthalmology, Veterans General Hospital, Yang-Ming Medical College, Taipei, Taiwan, Re­public of China.

Address for reprints: M.Y. Yen, MD, Department of Ophthalmology, Veterans General Hospital, Taipei, Taiwan, ROC, 112.

Page 2: Comparison of the Effect of Atropine and …art45-paediatric-studies-docs.ema.europa.eu/GROUP C/Cyclopentolate...Comparison of the Effect of Atropine and Cyciopentoiate on Myopia MAY-YUNG

ropine 1 % eye drops every other night, and refraction was rechecked two weeks later. Bi­focal glasses were prescribed at this time. Then, the patients were followed up every three months for vision, refraction, fundusco­py, and intraocular pressure. The second group received cyclopentolate 1% eye drops every night. Single-vision glasses were pre­scribed if necessary. Then, the patients were followed every three months for vision and re­fraction. The third group received normal sa­line eye drops every night as a control. Single­vision glasses were prescribed if needed. The patients were followed every three months for vision and refraction.

To avoid deviation during retinoscopy, all examinations were done by three doctors. Ev­ery patient was followed by the same doctor. Patients who discontinued the eye drops or who did not use them regularly were excluded from the study.

Patients who used the eye drops continu­ously for one year received another complete ophthalmologic examination, including vision, keratometry, axial length, funduscopy, in­traocular pressure, and cycloplegic refraction at the end of one year. (The atropine group became cycloplegic through use of atropine.) In October 1986, 96 such patients were col­lected for evaluation, 32 in each group. The mean age was 10.5 years old in the atropine group, ten years old in the cyclopentolate group, and 10.4 years old in the control group.

In the atropine group, refraction was ana­lyzed after two weeks of medication and at the final visit. In the cyclopentolate and the con­trol group, refraction was analyzed before treatment and at the final visit. All refractions were listed as spherical equivalents, and only the right eyes were evaluated.

Results

The Figure shows the distribution of refrac­tion error of three groups before treatment. There was no statistically significant differ­ence between the three groups (Table I). Af­ter one year of treatment, the mean progres­sion was -0.219D in the atropine group, -0.578D in the cyclopentolate group, and -0.914D in the control group. The differences were statistically significant (Table II).

When we compared the effect of atropine and saline, cyclopentolate and saline, and at­ropine and cyclopentolate, all differences were

10

Volume 21 Number 5 Myopia 181

30 REFRACTION ERROR

_ ATROPINE

o N.CL

~ CYCLOGYE

40

Figure. Distribution of refraction error of three groups be­fore treatment.

Table I Mean Refraction Error Before Treatment

Mean Standard Deviation

Atropine Cydopentolate Saline

-1.523D -1.453D -1.586D

±0.960D ±0.846D ±0.915D

By analysis of variance: P> .05; The diopters are in spher­ical equivalents for the right eye only.

Table II Mean of Myopic Progression

Mean Standard Deviation

Atropine Cydopentolate Saline

-0.219D -0.578D -0.914D

±0.538D ±0.490D ±0.58lD

By analysis of variance: P < .01. The diopters are in spher­ical equivalents for the right eye only.

Table III Comparisons of the Effect Between Atropine and Saline, Cydopentolate and Saline, and Atropine and Cydopentolate

Atropine (-0.219D):Saline (-0.9l4D) P < .01 Cydopentolate (-0.578D):Saline (-0.914D) P < .01 Atropine (-0.219D):Cydopentolate (-0.578D) P < .01

By the Scheffe method.

statistically significant (P < .01) (Table III). This means that atropine and cyclopentolate

Page 3: Comparison of the Effect of Atropine and …art45-paediatric-studies-docs.ema.europa.eu/GROUP C/Cyclopentolate...Comparison of the Effect of Atropine and Cyciopentoiate on Myopia MAY-YUNG

182 Annals of Ophthalmology May 1989

Table IV Myopic Progression in Three Groups

Atropine

No. of eyes %

No change Progression .$ -0.5D Progression -0.51 to -1.OD Progression> - I .OD Total

18 7 6 1

32

56% 22% 19%

3% 100%

can retard myopic progression. The effect of atropine was better than that of cyclopento­late.

Table IV shows the distribution of progres­sion in the three groups. There were 78% in the atropine group, 60% in the cyclopentolate group, and 37% in the control group, whose myopic progression was within -0.5D. There were 6% in the control group whose refraction did not change at all during the study period. There were 3% in the atropine group whose myopia progressed more than -ID.

The following side effects occurred. All pa­tients in the atropine group had photophobia. Most of them stopped gymnastic classes in school, and they did not like to go outdoors on weekends. This was not observed in the cyclo­pentolate or control groups. Many patients dropped out of the study. Except for photo­phobia in the atropine group, patients com­plained that it was inconvenient to use the eye drops every night and after several weeks, they discontinued the drops. No systemic or ocular complications were observed during this study.

Discussion

Excessive close work has been thought to be the main cause of myopia. For years, cyclo­plegics have been used to try to control myo­pic progression. Wells!! is credited as the originator of atropine treatment for myopia. Since Bedrossian's study in 1964, there have been several reports3- 9 of favorable results in low myopia as a result of atropine treatment. Most of these studies were retrospective and not randomized.

We did a prospective, randomized study, using atropine 1 % as a strong cycloplegic, cy­clopentolate 1 % as a moderate cycloplegic, and normal saline as a control. The results showed that atropine and cyclopentolate slow

Cl'c1opentolate Saline

No. of eyes % No. of eyes %

6 19% 2 6.25% 13 41% 10 31.25% 9 28% 10 31.25% 4 13% 10 31.25%

32 100% 32 100%

myopic progression. The effect of atropine was better than that of cyclopentolate. The mean progression was -0.219D in the atro­pine group, -0.578D in the cyclopentolate group, and -0.914D in the saline group.

Although atropine delays the progression of myopia, it does not arrest the tendency for progression in susceptible persons. There were 3% in the atropine group whose myopia pro­gressed more than -1.0D in one year. Sampson 7 found that all patients had rapid progression when atropine was discontinued. Brodstein8 suggested that the treatment pro­gram should be extended to at least 16 years of age. Although long-term atropinization may be valuable in the management of func­tional myopia, it may be too costly.

Atropine and cyclopentolate can induce se­vere ocular and systemic side effects and must be prescribed with care. Safir lO criticized the use of atropine in children because of the pos­sible hazards including the retina's reception of 25 times more solar energy when the pupils were dilated fully.

Even though their spectacles were sun­glasses with ultraviolet inhibitors, all patients in the atropine group complained of photo­phobia. Most stopped gymnastic classes in school and outdoor life on weekends. This was not observed in the cyclopentolate or saline groups. Even though the physiologic side effects of long-term atropinization may be proved to have no significant sequelae on the eye and its function, the psychologic effects of such a forced regimen in children for such a benign condition as school myopia are serious.

Although cyclopentolate is not as potent as atropine, it has less side effects. One drop at bedtime caused a few patients to have diffi­culty with near vision the next morning, but most tolerated it well. During treatment, it is effective in 60% of patients. (Myopic progres-

continued on page 187

Page 4: Comparison of the Effect of Atropine and …art45-paediatric-studies-docs.ema.europa.eu/GROUP C/Cyclopentolate...Comparison of the Effect of Atropine and Cyciopentoiate on Myopia MAY-YUNG

References

1. Henderson RL, Burg A: Driver screening for night driving. Transportation Research Board Special Report 156. Washington, DC, U.S. Government Printing Office, 1975; 74-89.

2. Sturgis SP, Osgood DJ: Measuring the quality of drivers' night vision. Proc Human Factors Soc 1981; 25:38-42.

3. Sturgis SP, Osgood DJ: Effects of glare and back­ground luminance on visual acuity and contrast sensi­tivity: Implications for driver night vision testing. Hu­man Factors 1982;24:347-360.

4. Campbell FW, Robson JG: Application of Fourier analysis to the visibility of gratings. J Physiol Land 1968;197:551-566.

5. Patel AS: Spatial resolution by the human visual sys­tem. The effect of mean retinal illuminance. J Optom Soc Am 1966;56:689-694.

6. Hess RF, Woo G: Vision through cataracts. Invest Ophthalmol Vis Sci 1978;17:428-435.

continued from page 182

sion was less than -O.5D.) Not all myopia progresses at the same

speed. Refraction did not change at all during the study period in 6% of the saline group. Due to the possible side effects of atropine, we suggest cyc1opentolate 1 % as the first-line medication for arresting myopic progression. If this fails, then atropine can be used.

References

1. Young FA, Beattie R, Newby FJ: The Pullman study: A visual survey of Pullman school children. Am J Optom Physiol Opt 1954;31:192.

2. Richard A, Bear JC: Refraction, near work and edu­cation: A population study in New Foundland. Acta Ophthalmol (Copenh) 1980;58:468-470.

3. Bedrossian RH: The effect of atropine on myopia. Ann OphthalmoI1971;3:891-897.

4. Bedrossian RH: The effect of atropine on myopia.

Volume 21 Number 5 Glare 187

7. Arden G: Measuring contrast sensitivity with gratings: A new simple technique for the early diagnosis of ret­inal and neurological disease. J Am Optom Assoc 1979;50:35-39.

8. Paulsson L-E, Sjoestrand J: Contrast sensitivity in the presence of a glare light. Theoretical concepts and preliminary clinical studies. Invest Ophthalmol Vis Sci 1980;19:401-406.

9. Hirsch RP, Nadler MP, Miller D: Glare measurement as a predictor of outdoor vision among cataract pa­tients. Ann OphthalmoI1984;16:965-968.

10. Jaffe N: Glare and contrast: Indications for cataract surgery. J Cataract Refract Surg 1986;12:372-375.

11. Levi L: Applied Optics, vol. 2. NewYork,John Wiley, 1980.

12. National Academy of Sciences-National Research Council Committee on Vision: Recommended stan­dard procedures for the clinical measurement and specification visual acuity. Adv Ophthalmol 1980; 41:103-148.

Ophthalmology 1979;86:713-717. 5. Kelly TSB, Chatfield C, Tustin G: Clinical assessment

of the arrest of myopia. Br J Ophthalmol 1975; 59:529-538.

6. Dyer JA: Role of cycloplegics in progressive myopia. Ophthalmology 1979;86:692-694.

7. Sampsom WG: Role of cycloplegia in the manage­ment of functional myopia. Ophthalmology 1979; 86:695-697.

8. Brodstein RS, Brodstein DE, Olson RJ, et al: The treatment of myopia with atropine and bifocals. A long-term prospective study. Ophthalmology 1984; 91:1373-1378.

9. Brenner RL: Further observations on the use of atro­pine in the treatment of myopia. Ann Ophthalmol 1985;17:137-140.

10. Safir A: Discussion of presentation by Dr. Robert H. Bedrossian. Ophthalmology 1979;86:718.

11. Curtin BJ: The Myopias: Basic Science and Clinical Management. Philadelphia, Harper & Row, 1985; 222.