Study of The Effects of Various Intraocular Pressure Reducing Drugs in Reducing Postoperative Rise in Intraocular Pressure after Cataract Surgery

 

Bansal Manish, Viswnadham K. K., Thakur Amit K., Sanat Singh, P.K. Kar, Khan Q.H., Shrivastav P.K.

Govt. Medical College, Jagdalpur  (CG)Bastar.

ABSTRACT:

Methods: This post operative randomized double masked clinical trial comprised patients with age related cataract having undergone extracellular cataract extraction (ECCE) with or without posterior chamber Intra ocular lense implementation (PC-IOL).They were randomly assigned to use topical timoilol or betaxolol or levobunalol or acetazolamide or intracameral pilocarpine (Group 1a/1b/1c/1d/.1e) respectively at the completion of the surgery. Two controls were taken- a.Intra-ocular pressure in the follow eye (Control-I) b. Intraocular pressure in the operated eye ,in which no Introcular pressure reducing drugs had been instilled (Control-II ) (Group-II). Intra-ocular pressure (IOP) was measured 6 hours, 24hours,3rd day,7th day and 2nd month postoperatively. The anterior chamber was examined for the levels of cells and flare using slit lamp examination.

Results :Levobunalol was more effective in reducing post operative IOP rise at 6 hours of surgery ,3rd day ,7th day 1st month, and 2nd month where as Timolol was more effective at 24 hours. There were significant difference in IOP between Group –I (those patients who received topical iop reducing drugs )and group –II (operated patients without any IOP reducing drugs )post operatively ( p<0.05).No excessive postoperative inflammation was observed in any group. In the control group –I (fellow eye), IOP remained constant throughout the period. This indicated that the drugs were not playing any major role in altering IOP of the fellow eye. In the control II (group –II), maximum mean pressure rise was 18 mm Hg at six hours .This indicated that it was the operative procedure that was causing the rise in IOP .Diurnal variation in IOP was playing no significant role.

 

KEYWORDS: Cataract, Intraocular pressure

 

INTRODUCTION:

Cataract surgery has been associated with post operative intra ocular pressure elevation .It is a well documented phenomenon that IOP reaches its highest between 6 and 8 hours after cataract extraction. This rise in IOP may lead the complications like Ischaemic optic neuropathy, corneal oedema ,deterioration of visual fields in glaucomatous eye ,retinal vascular occlusion and inhibition of wound healing. Keeping in mind the above facts and in 1957 a study group of World Health Organization (W.H.O.) has expressed the view that in order to get a comprehensive picture of the disease (health problem) ,more and more studies have to be carried out(1). This prompted the authors to under take this study was to evaluate the effects of IOP reducing drugs instilled preoperatively, on the pattern of IOP changes after cataract surgery ,to compare the efficacy of these drugs in controlling early postoperative rise of IOP and to observe the pattern of IOP changes in the contralateral eye (Phakic, Pseudophakic, Aphakic) following cataract surgery.

 

 

 


MATERIALS AND METHODS:

This post operative randomized double masked clinical trial study comprised patients with age related cataract having undergone extracellular cataract extraction (ECCE) with or without posterior chamber Intra ocular lense implementation (PC-IOL).They were randomly assigned to use topical timoilol or betaxolol or levobunalol or acetazolamide or intracameral pilocarpine (Group 1a/1b/1c/1d/.1e) respectively at the completion of the surgery .Two controls were taken-

 

a.Intra-ocular pressure in the follow eye (Control-I)

b. Intraocular pressure in the operated eye, in which no Introcular pressure reducing drugs had been instilled (Control-II ) (Group-II)

 

c.Group- I as patients who had been given timoilol or betaxolol or levobunalol or acetazolamide or intracameral pilocarpine at the completion of the surgery in the operated eye.

 

Intra-ocular pressure (IOP) was measured 6 hours, 24hours, 3rd day, 7th day and 2nd month postoperatively. The anterior chamber was examined for the levels of cells and flare using slit lamp examination.

 

A total of 105 patients were included in this study. There were 20 patients each in the topical timoilol or betaxolol or levobunalol or topical acetazolamide. There were 25 patients in intracameral pilocarpine group. Proper history taking including chiefs complaints, history of present illness, negative history, past history, family history, and personal history of each patients were recorded in a predawn proforma. The patients were examined preoperatively and then after 5-7 hours, 1 day,3 days, 7 days, 1 month, and 2-4 months postoperatively. The examination included visual acuity after full refractive correction ,torch light examination ,slit lamp examination, macular function test ,fundus examination ,and IOP measurement by both application and schitoz tonometry.IOP pattern was observed in each group ,inter group comparisons were made and results were derived to draw conclusions. Mean (Average) ± 1S.D. (Standard Deviation), Student’s t-test the chi –square test were used to test the statically significance of differences in IOP between the different groups when appropriate.

 

OBSERVATIONS AND DISCUSSIONS:

Average age of patients in the study was 59 years (range between 38 to 75 years). Majority of the patients (33.3%) were in the age group of 51 to 60 years. Out of total 105 patients in the study, 54 (51.1%) females and 51(48.9%) were males. Out of total cataract surgeries conducted, 57 (54.0%) were extra capsular cataract extractions without PC-IOL implantation and 48 (46.0%) extra capsular extractions with PC-IOL implantation. The selected drugs were instilled at the end of surgery and following observations were recorded :-

Timolol Group-

After 6-8 hours, 1st, 3rd and 7th day postoperatively the mean IOP was significantly lower in the Timolol group in comparison to control group –II and the decrease was statically significant (p < 0.05 ).The mean IOP was still lower after 1 month and 2-4 months postoperatively as compared to the control group ,but it was not statically significant (p>0.05). The maximum decrease in IOP  after surgery in Tiomolol group was 3.50± 0.17 mm Hg at 24 hours after surgery. The average increase in IOP reached in control group –II was 4.00 mm Hg. The mean pressure in the fellow eye (control –I)remained steady (14.20 mm Hg) throughout the study period.

 

Betaxolol Group: 24 hours postoperatively the mean IOP was 11.70 ± 2.28 mm Hg in this group which was significant as compared to the preoperative IOP of 14.30 ±2.03 mmHg .At 1 month and 2 month after surgery, there was no significant difference in IOP in Betaoxolol and control group-II.The mean pressure in the following eye (Control-I) remained steady 12.30 mm Hg throughout study period. The average maximum IOP reached in control –II was 18.00 ± 3.02 mm Hg at 24 hours after cataract surgery.

 

Levobunalol Group: After 6-8 hours ,1st ,3rd ,7th day postoperatively the mean IOP was significantly lower in the Levobunalol group than in the control group –II and the decrease was statically significant (p<0.05).The mean IOP was still lower after 1month and 2-4 months postoperatively in the Levobunalol group as compared to the control group–II, which was statistically insignificant(p>0.05). The average (mean) of the maximum rise of IOP after surgery was 4.0 mmHg .The average (mean)of the maximum decrease in IOP was 3.20 ±0.45 mmHg.

 

Topical Acetazolamide Group: In this treated group at 6-8 hours, 24 hours, 3rd day, 7th day postoperatively statistically significant decrease in IOP compared to control group –II. Mean IOP WAS 11.00 ± 2.32 mm Hg ,11.00 = 2.30 mmHg ,11.40 =2.16 mmHg and 12.00 = 2.10 mmHg at 6-8 hours ,1st day ,3rd day and 7th day respectively in the topical acetazolamide group compared to its preoperative IOP of 13.60 ± 2.48 mm Hg .The mean pressure in the fellow eye (control-I)remained steady 13.60 mm Hg throughout type study period. The average (mean) of the maximum decrease IOP after surgery in this group was 2.60 ± 0.18 mm Hg.

 

Intra cameral Pilocarpine group : The lowest IOP value in this group was at 6-8 hours ,was 10.50 ±3.06 mm Hg as compared to its preoperative value of 12.20 ±2.76 mm Hg .At the same time the mean IOP of the control Group-II was 18.00 ±2.80 mmHg as compared to preoperative IOP of 14.00 ± 1.41 mm Hg. twenty four hours and 3rd day postoperatively ,the mean IOP of the pilocarpine group was 11.00 ±3.40 mm Hg and 11.40 ± 2.68 mm Hg respectively ,while that in the control group –II  was  18.00 ±3.02 mm Hg and 16 .00 ±2.64 mm Hg respectively. These difference were statistically significant .The mean pressure in the fellow eye (control-I) remained steady 12.80 mm Hg through the study period.

 

Comparison (2) of various IOP reducing drugs :

a.       In the first six hours after surgery ,most reduction in post operative IOP was maintained in topical Levobunalol group (22.60 %) followed by Timolol (22.0 %), Acetazolamide (19.0%), Betaxolol (16.0%) and Pilocarpine group (13.9%).

b.      In the first 24 hours after surgery, most reduction in post operative IOP             was maintained in topical Timolol group (26%) followed by Levobunalol (23 %), Acetazolamide (19 %) Betaxolol (18%) and Pilocarpine group (13.9%).

c.       In the 3rd day after surgery, most reduction in post operative IOP was maintained in topical Levobunalol group (20.5 %) followed by Timolol (18.5%), Betaxolol (16.70%) Acetazolamide (16 %) and Pilocarpine group (6.5%).

d.      In the 7th day after surgery, most reduction in post operative IOP was maintained in topical Levobunalol group (20.50%) followed by Betaxolol (13.2%) ,Acetazolamide (11.7%), Pilocarpine (9.8%) and Timolol  (6 %).

e.       In the first month after surgery, most reduction in post operative IOP was maintained in topical Levobunalol group (15.60%) followed by Betaxolol (11.8%), Pilocarpine (8%),Timolol (1.5%) and Acetazolamide group (0.7%).

f.       In the 2nd month after surgery, most reduction in post operative IOP was maintained in Levobunalol group (6.9%) followed by Timolol (3.70%), Pilocarpine (2.5%), Betaxolol (2%) and acetazolamide group.

 

CONCLUSIONS:

From above observations and discussion the authors reached to the conclusion that in the present study Levobunalol in a concentration of 0.5 %instilled preoperatively just after cataract surgery is more effective in reducing postoperative IOP rise following cataract surgery than any other drugs and is also most effective in dealing with the complications arising from raised IOP.

 

There is so many prejudices in the community about Cataract surgery .All these can be removed by proper and scientific impartation of knowledge in the community through the various mass medias (3) like Television, Radio, local traditional media’s like folk dances and folk songs.

 

REFERENCES:

1.       Garg Narendra K. Evaluation of the impact of emesis and emesis plus purgation therapy; Research J Pharmacology and Pharmacodynamics :2(2) March-April 2010;201-2.

2.       Bansal Manish :A comparative study of the effectiveness of various drugs in preventing post-operative intra ocular pressure rise following cataract surgery ;Thesis for M.S. (Ophthalmology) 2001 submitted to AMU, Aligarh (UP)

3.       Garg Nrendra K.and Bansal A.K.: Management of information system in context  of health care delivery; J. Ravishankar University :Vol.14 ,No-B(Science )2001; pp35-40

4.       Bansal A.K., Ram R.C., Dixit S., Thaker N.N. and Adile S.L.; “A macro level community diagnosis of eye health care programme in – low socio-economic strata community” Silver Jubilee Conference of IAPSM, Department of Community Medicine Gandhi Medical College, Bhopal; 23rd, 24th and 24th October 1997.

5.       Shukla P., S. K. Shukla and  Bansal A.K ‘Knowledge, Attitude and Practice Study of Tribal and Nontribal People Of A Slum about Eye Health Care’. Research J. Pharmacology and Pharmacodynamics. 2011, 3(5), 289-291 

 

Received on 05.06.2011

Modified on 16.01.2012

Accepted on 15.02.2012                                               

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Research J. Pharmacology and Pharmacodynamics. 4(2): March - April, 2012, 116-118