(ADDOR11)PRELIMINARY RESULTS OF PROTECTIVE EFFECTS OF BIO-NORMALIZER AGAINST POST-OPEREATIVE COMPLICATIONS OF PHOTOREFRACTIVE

Title PRELIMINARY RESULTS OF PROTECTIVE EFFECTS OF BIO-NORMALIZER AGAINST POST-OPEREATIVE COMPLICATIONS OF PHOTOREFRACTIVE
Year  1999
Author  Dr. Igor Ovechkin, Dr. Alexander Shakula, Professor Ludmila Korkina, 
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PRELIMINARY RESULTS OF PROTECTIVE EFFECTS  OF BIO­ NORMALIZER AGAINST POST-OPERATIVE COMPLICATIONS OF PHOTOREFRACTIVE KERATECTOMY IN ACTIVE DUTY RUSSIAN MILITARY PERSONNEL

 

 

Clinical Investigators- Dr. Igor Ovechkin, MD, PhD, Dr. Sci., Head,

Ophtalmology Unit, 6th Central Military Clinical Hospital, Moscow, Russia

 

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Dr. Alexander Shakula, MD, PhD, Dr.Sci., Head, Rehabilitation  Department, 6th

Central Military Clinical Hospital, Moscow, Russia

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Tel: (7095) 455 9300

 

Scientific Supervisor – Professor Ludmila Korkina, MD, PhD, Dr. Sci., Head,

Department of Molecular Biology, Russian State Medical University

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Tel/Fax: (795) 434 7187

E-mail: korkin@a ha.ru

Moscow, 1999

 

 

Objectives

 

Standard  optical  devices  (eyeglasses  and  lenses)  are  often  inadequate  to  correct myopia   in  military  personnel.   Thus, myopic   privates and on-duty-offices   have difficulties in finding suitable refractive correction because of their wide variety of operational duties, including running, jumping, night driving, parachuting, swimming, etc. At the circumstances, spectacles quickly can become dirty and scratched in sandy, I marshy, or muddy terrain.  Contact lenses offer some advantages, including compatibility with diving face masks, night vision devices, and parachute goggles. However, proper lens hygiene is very difficult or even impossible to maintain while in the field conditions.  Furthermore, contact lenses may cause ocular discomfort during a typical period of continuous more than 24 hours activity.  A safe and effective refractive surgical   procedure could substantially   benefit service   personnel   with myopia.

Simple non-complicated by astigmatism myopia has been successfully treated with photorefractive keratectomy (PRK) during last decade. The details of PRK surgical procedure and reports of numerous clinical trials have been published worldwide (1-4).

 

Despite the ability to reduce myopia and improve uncorrected vision, there are unanswered questions regarding the “quality of vision” and some complications such as slow healing process, pain and haze in the post-operative period.

 

This study aimed to prevent or ameliorate some common complications after PRK surgery using a short-term systemic and topical Bio-Normalizer application.

 

Clinical study design and patients’ assessment

 

Forty male service men underwent PRK for the correction of myopia. The  protocol and  case  report  form   of  the  clinical  study  (PRK   operation   and   post-operative procedures)  were  approved  by  the  Etique  Committee  of  the  6′h Central  Military Clinical  Hospital,  Moscow,  Russia.  Eligibility criteria included a stable refractive error between -1.5 and -6 diopters, D (Group I, 23 patients) and -6 to – 11 diopters  (Group II, severe near sighting, 17 patients). All participants were with no more than 1 D of astigmatism, normal ocular health, and intolerance to eyeglasses and contact lenses. Subjects had to be 21 years of age (mean age 26±6 years, age range 21 -44 years) or older and active-duty military. Hard contact lenses users were required not to wear the lenses for at least 3 weeks before the preoperative period. For those with soft lenses the refraining period was 1 week before the PRK operation.

 

Informed consent was obtained from each participant after an extensive question  and answer  session  on  PRK  itself  and  Bio-Normalizer   in  particular,  including  risks, benefits, and alternatives. The research purpose of the study was explained in details. All participants were given 1 sachet of BN one hour before the operation and 1 sachet of BN one hour after the PRK. Then, the patients received topical BN application (as 5% and 10% drops, 2 drops x 5 times a day for 4 days after operation) to experimental eye. The control eye of the same patients received the solution of “artificial” tear (2 drops x 5 times a day for 4 days after operation).

 

All  photoablations   were  carried  out  by  an  experienced   refractive  surgeon  (Igor Ovechkin,  MD, PhD,  Dr. Sci.)  With the 193 nm ES-5000 excimer laser (NIDEK, Japan) using a 6-mm diameter ablation zone. According to manufacturer information the lazer delivered an intermittent energy density of 180 mJ/cm2 a pulse repetition rate  of  10Hz, and  an  ablation  depth  of  0.25  μm/pulse.  Total ablation depth was determined by the NIDEK algorithm after the refractive data were download to the lazer. The patients’ pupil was constricted, and anesthesia was obtained with topical procaine. Then, several lazer pulses were applied onto the corneal epithelium. The destroyed epithelium was removed with a blunt spatula to clear the central 6-mm zone. Finally, corneal surface was smoothed with metylcellulose and dried with a sponge. Postoperatively, the patients received conventional therapy with ointment and drops. Additionally, the experimental eye received BN drops according to above scheme.

 

Postoperative testing.

The patients were examined daily until complete re-epithelization.  To evaluate  the efficacy  of  BN,  the  examinations  consisted  of:  (1)  uncorrected  visual  acuity;  (2) postoperative pain; (3) duration of full re-epithelization; (4) postoperative haze.

 

Results.

The mean values of baseline myopia for experimental and control eyes and operative intervention to both eyes did not differ each from other (Table 1).

 

The preliminary phase II clinical investigation revealed positive therapeutical effect of combinatory (systemic and topical) BN administration to military men subjected to PRK (Fig.  1-8). The vision acuity in the experimental eye of the first group of patients was 0.13, 0.02, and 0.08 D higher than in the control one at the 4th,   14th  and 30th  day, respectively. The score of post-operative haze was 0.08-0.36 arbitrary units lower than in the control eye. The pain in the operated eye was 1.7-fold less intensive in the experimental vs control eye. The  BN-induce  improvement  of corneal  healing  was proven  by the  increased  number  of complete  re-epithelization  by the  4th day after operation  (Fig.  1 -4).  In the second group of patients with severe   myopia, BN administration   increased   vision  acuity  (or  decreased   a  degree of  non-corrected myopia)  by  0.08,  0. 1 , and  0.07  0 at  the  4th,  14th and  30th  postoperative  days, The haze decreased  (by 0.12-02 arbitrary units ) and the ocular pain was less intensive for the experimental  eye (11 % difference between the groups). The corneal healing was completed by the 4th day after operation in 91% of patients of the experimental group and in 84% of the control patients (Fig. 5-8).

 

Conclusions.

 

The preliminary results of the trial allowed  us to suggest that BN prescribed  both in powder  and  eye  drop  forms  to  the  patients  subjected  to  PRK  could  improve  the quality   of   vision   and   diminish   the   frequency   and   intensity   of   post-operative complications.   However,  the  optimization   of  the  scheme  of  BN  pre-  and  post­ operational administration  has to be further evaluated.

 

References.

 

  1. Schallhorn  S.C., Blanton  Ch. L., Kaupp S.E., Sutphin  J., Gordon M., Goforth  H., and Butler F.K., Ophthalmology, 1996, 103, 5-22
  2. Lanzetta P., Menchini U., and Virgili G., Br. J. Ophtalmol, 1999, 83,29-32
  3. Thomas J.V., Simmons R.J., and Belcher C.D., Ophthalmology, 1982, 89, I 87-197
  4. cDonald M.B., Liu J.C., Byrd, T.J., et al., Ophthalmology, 1991, 98, 1 327-1337

 

 

Table 1 Baseline characteristics for clinical groups

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