Höh H, Schwanengel M
Klinik für Augenheilkunde im Dietrich-Bonhoeffer-Klinikum Neubrandenburg, Salvador-Allende-Strasse 30, 17036 Neubrandenburg.
Klin Monbl Augenheilkd. 2006 Nov;223(11):918-23. doi: 10.1055/s-2006-927103.
The aim of this observation study was to determine whether regression of lid-parallel conjunctival folds (LIPCOF) can be induced by repeated and intensive treatment with a gel-forming tear substitute.
In cooperation with the referring ophthalmologists, patients suffering from advanced dry eye condition were recruited. LIPCOF grades from 1 to 3 were included. Tear film break-up time (BUT) had to be less than 10 sec and the Schirmer-I test less than 10 mm. All patients recruited had been using watery tear substitutes. Examinations including visual acuity, slit lamp, fluorescein test, Schirmer-I test, BUT, LIPCOF were performed at baseline and after 2 weeks and 2 months. All examinations were done by the same physician at the Dietrich-Bonhoeffer Eye Hospital of Neubrandenburg. Exclusion criteria were severe eye diseases such as glaucoma, cataract, retinal detachment, history of intraocular or conjunctival surgery and disorders of the eye lids. Pretreatment with gels was not allowed. In the study, patients were treated with Liposic Eye Gel at least three times a day for a period of two months.
LIPCOFs regressed in 10 eyes of 5 patients (1 x male, 4 x female) from a mean grade of 2.58 at baseline to 2.29 after 2 months under Liposic treatment. This improvement is statistically significant (n = 10, p = 0.04). Schirmer-I test results had improved in the same time period from a mean of 6.4 mm at baseline to a mean of 8.1 mm after 2 months (n. s., n = 10, p = 0.73). BUT improved from a mean of 12.5 sec at baseline to a mean of 17.5 sec at the 2-month follow-up (n. s., n = 10, p = 0,085). In one patient the cornea was fluorescein-positive at baseline and stayed so throughout the follow-up. Liposic Gel was used by the patients between 3 to 8 times per day. Tolerance was excellent.
The study results show that the morphological signs of the dry-eye condition like LIPCOFs can be reversed by intensive treatment with Liposic Gel. The improvements in BUT and Schirmer-I test results confirm the adherence of the patients to the treatment schedule.
This pilot study provides the statistical data necessary for designing a major treatment study to prove not only the reversibility of LIPCOF, but also the dependence of the possible improvement on the grade of LIPCOF stage on the age of the patient and on other criteria.
本观察性研究的目的是确定反复密集使用凝胶型人工泪液替代品是否能促使睑结膜平行皱襞(LIPCOF)消退。
与转诊的眼科医生合作,招募患有严重干眼症的患者。纳入LIPCOF分级为1至3级的患者。泪膜破裂时间(BUT)必须小于10秒,泪液分泌试验(Schirmer - I试验)必须小于10毫米。所有招募的患者一直在使用水性人工泪液替代品。在基线、2周和2个月后进行包括视力、裂隙灯、荧光素试验、Schirmer - I试验、BUT、LIPCOF在内的检查。所有检查均由新勃兰登堡迪特里希 - 朋霍费尔眼科医院的同一位医生进行。排除标准为严重眼部疾病,如青光眼、白内障、视网膜脱离、眼内或结膜手术史以及眼睑疾病。不允许预先使用凝胶。在研究中,患者每天至少使用三次Liposic眼用凝胶,持续两个月。
5例患者(1例男性,4例女性)的10只眼中,LIPCOF在Liposic治疗下从基线时的平均2.58级消退至2个月后的2.29级。这种改善具有统计学意义(n = 10,p = 0.04)。泪液分泌试验(Schirmer - I试验)结果在同一时期从基线时的平均6.4毫米改善至2个月后的平均8.1毫米(无统计学意义,n = 10,p = 0.73)。BUT从基线时的平均12.5秒改善至2个月随访时的平均17.5秒(无统计学意义,n = 10,p = 0.085)。1例患者在基线时角膜荧光素染色阳性,在整个随访过程中一直如此。患者每天使用Liposic凝胶3至8次。耐受性良好。
研究结果表明,像LIPCOF这样的干眼症形态学体征可以通过Liposic凝胶的强化治疗得到改善。BUT和泪液分泌试验(Schirmer - I试验)结果的改善证实了患者对治疗方案的依从性。
这项初步研究提供了设计大型治疗研究所需的统计数据,不仅要证明LIPCOF的可逆性,还要证明可能的改善对LIPCOF分级、患者年龄和其他标准的依赖性。