BACKGROUND The Early vs Late Infantile Strabismus Surgery Study Group investigates whether early or late surgery is preferable in infantile convergent strabismus, in a non-randomised, prospective, multicentre clinical trial. The current state of the study after end of recruitment is reported here, focusing on the question of possible sources for bias in this non-randomised trial. METHOD The prognostic factors were analysed at baseline in order to check for imbalances between the two treatment groups. Reasons for possible differences are discussed. RESULTS There is no evidence for clinically relevant inhomogeneities between the two groups concerning the distribution of the three prognostic factors spherical equivalent, degree of amblyopia, and limitation of abduction. The fourth prognostic factor, horizontal angle of squint, differs significantly between the two groups. CONCLUSION In the analysis of the final results we may have to account for differences in angle of squint at baseline by its inclusion as a covariate or by stratification.

https://bjo.bmj.com/content/bjophthalmol/82/8/934.full.pdf

The Early vs Late Infantile Strabismus Surgery Study: do sources for bias exist in this non-randomised trial?

The Early vs. Late Infantile Strabismus Surgery Study Group is a group of strabismologists and orthoptists who investigate whether early or late surgery is preferable in infantile strabismus, in a non-randomized, prospective, multi-centre trial. Infants between 6 and 18 months of age will receive a standardized entry examination and then be operated either before their second anniversary in clinics A, or between their 32nd and 60th month of age in clinics B. The children will be evaluated at age six. After completion of the study, the two groups can then be compared regarding degree of binocular vision, angle of strabismus and visual acuity of the worse eye relative to the better. Zentrum zur methodischen Betreuung von Therapiestudien, Mrs H. Dinkel, Universitat Heidelberg, Im Neuenheimer Feld 305, W-69120 Heidelberg. 49.6221.565500. fax: 564195 Germany PD Dr. H.J. Simonsz, Orthoptics & Neuroophthalmology, Afdeling Oogheelkunde, University Hospital Dijkzigt, Dr. Molewaterplein 40, NL 3015 GD Rotterdam. 3 i. 10.4639222, ask for beeper 3394 fax: 4635105 The Netherlands PD Dr. med. G.H. Rolling, Schule fur Orthoptik, Universitats-Augenklinik, Im Neuenheimer Feld 400, W-69047 Heidelberg. 49.6221.566627/34/39 fax: 565422 Germany Dipl.-Inform. Med. U. Haag, Universitat Heidelberg, Zentrum zur methodischen Betreuung von Therapiestudien, Im Neuenheimer Feld 305, W-69120 Heidelberg. 49.6221.564192 fax: 564195 Germany Dr. A. Deak, Augenklinik, Koranyi Fasor, U-6720 Szeged. 36.62.12321/10822 fax: 22826 Hungary Mr P. Fells, F.R.C.S., F.C. Ophth., Lower Corridor Suite, Moorfields Eye Hospital, City Road, ECIV 2PD London. 44.71.2533411 fax: 2534696 (lower corridor suite) England Prof. R. Frosini, Istituto di Clinica Oculista dell' Universita di Firenze, Insegnamento di Ottica Fisiopatologica, Viale Morgagni 85,1-50134 Florence. Dr. R. Gomez de Liano, Nunez de Balboa 81, E-28006 Madrid. 34.1.5763229/72318 Spain Dr. O. Haugen, Orthoptic Department, Department of Ophthalmology, University of Bergen, N-3021 Bergen. Norway Dr. med. G. Klainguti, Clinique Ophtalmique, 15 Av. de France, CH-1004 Lausanne. 41.21.9637696/250211 Switzerland Prof.Dr. K. Krzystkowa, Ophthal. Clinic Medical Acad., 38 Copernika Str, P-31501 Krakow. 4812.223272/215210/210460/214577/220411 Poland M.C.M.E. van Lammeren, Afdeling Orthoptie, Dienst Oogziekten, U.Z. St. Rafael, Kapucijnenvoer 33, B-3000 Leuven. Prof. G. Lennerstrand, Institutionen for Oftalmiatrik, Huddinge sjukhus, S-14186 Huddinge. 46.8.7461000/3854/3418 Sweden Dr. med. H. Luka, Abt. f. Schielen, Schwachsichtigkeit und Bewegungsstorungen des Auges, Allgem. offentl. Krankenhaus der Landeshauptstadt St. Polten, A-3100 St. Polten. 43.512.85597/5040 43.2742.62521 (Klappe 2869) Dr. V. Paris, Rue de Luxembourg, 48, B-6900 Marche-en-Famenne. 32.84314749 Belgium Dr. L.J.J.M. Prick-Wenniger, Afdeling Oogheelkunde, A.M.C., Meibergdreef 9, NL 1105 AZ Amsterdam. 31.20.5663881/6715637 The Netherlands Prof. M.A. Quere, 19, Rue Voltaire, F-44000 Nantes. 33.40.738370/083406 fax: 084649 France Dr. F. Reich-d'Almeida, Rua Castilho, No 65.z:Dto, P-1200 Lissabon. 351.1520619 Dr. med. R. Weidlich, Universitats-Augenklinik, Leninallee 8, O-4020 Halle. 37.4684.9878/81 Germany.

/pdf/the-protocol-for-the-early-vs-late-infantile-strabismus-40tyxp85vr.pdf

The Protocol for the Early vs. Late Infantile Strabismus Surgery Study

Between 1984 and 1989, 79 patients were reexamined an average of 8 years after bimedial rectus muscle posterior fixation sutures. Patients who had to be operated additionally for vertical or cyclovertical motility disorders were excluded from the study. Seventy-five percent of the patients showed a residual deviation in the alternating prism and cover test of up to 5°. With Bagolini striated glasses 60 patients were found to have simultaneous perception at near and distance. The effects on convergence and lateral gaze were examined. After completed surgical therapy consecutive exotropia was found in 5% of all cases. In every 5th patient a reoperation was required. The study shows that bilateral posterior fixation suture of the medial rectus muscles leads to good long-term results in correcting infantile esotropia. Compared to other surgical techniques, significant advantage results from the low number of consecutive exotropias.

Long-term results after bimedial posterior fixation sutures for infantile esotropia.

Die operative Schielbehandlung soll eine moglichst stabile, normale Augenstellung und -beweglichkeit sowie ein beschwerdefreies, praktisch brauchbares beidaugiges Einfachsehen im Gebrauchsblickfeld schaffen (s. Kapitel VII. A). Bei manchen Berufen (z.B. Dachdecker) und bei Patienten mit versteifter Hals- und Brustwirbelsaule (z.B. Morbus Bechterew) mus man versuchen, uber diese Minimalforderung hinaus das physiologische Blickfeld zu normalisieren. Kann man die Bewegungsstorung nicht im ganzen Gebrauchsblickfeld beseitigen, sollte man dies wenigstens fur das zentrale und untere Blickfeld anstreben.

Chirurgie der äußeren Augenmuskeln

In groseren Statistiken werden ca. 50% Beteiligung von Vertikaldivergenzen an allen Schielformen angegeben. 2/3 davon sind schrage Hohenschielformen. Um binokulares Einfachsehen als Ziel jeder strabologischen Therapie erreichen zu konnen, mus folglich in etwa 33% aller Schielfalle ein Eingriff an den Obliqui erwogen werden. Dazu steht am Obl. sup. mit der Faltung uber dem Spatel nach de Decker eine zwar technisch anspruchsvolle, aber gut dosierbare Methode zur Verfugung, die auch nach Jahren in ihrer Wirkung nicht nachlast. Wir berichten anhand von 175 Operationen uber unsere Erfahrungen damit. Vertical deviations have a share of about 50% in all forms of strabismus as shown in extensive statistics. 2/3 of them are oblique vertical types. Only considering operations on oblique muscles, single binocular vision can be attained in these cases as aim of any strabological therapy. We have the disposal of the folding procedure of the superior oblique on a spatula created by de Decker—a method of technical intensity, but properly to dose. The results do not temper over years. We report on our experience in 175 operations.

Faltung des Obliquus superior

One hundred and forth-three patients suffering from infantile strabismus, who had undergone surgery on the horizontal eye muscles between the ages of 0 and 6 years were re-examined with the aim of establishing a correlation between the date of operation and functional healing (binocular single vision in space). In 89 patients (62%) a cosmetically satisfactory result (alignment) was achieved. The number of operations and functional healing (binocular single vision in space). In 89 patients (62%) a cosmetically satisfactory result (alignment) was achieved. The number of operations needed decreased with increasing age. Of the 89 patients with alignment, 61 (69%) were found to have binocular single vision in space, while 13 (15%) patients presented with stereopsis. Impairment of functional results was found to correlate with higher age at the first operation or on the date when alignment was reached for the first time, respectively. In cases with amblyopia or vertical divergences which had received insufficient postoperative treatment, attainment of binocular single vision or, respectively, the stability thereof was impaired. Therefore, with respect to functional healing, early surgical correction of strabismus is only recommended if adequate postoperative conservative and/or surgical after-treatment is assured. The postulate that successful functional healing can only be achieved by operations up to the second year (early surgery) is not supported by our data.

Prognosis of functional healing of infantile strabismus

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Prognosis of functional healing of infantile strabismus