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Prospective, randomized, double-blind trial to investigate the efficacy and safety of corneal cross-linking to halt the progression of keratoconus.

Lang SJ, Messmer EM, Geerling G, Mackert MJ, Brunner T, Dollak S, Kutchoukov B, Böhringer D, Reinhard T, Maier P - BMC Ophthalmol (2015)

Bottom Line: This difference was statistically significant (p = 0.02).Therefore, further investigations are necessary to decide which patients require treatment and which do not.NCT00626717, Date of registration: February 20, 2008.

View Article: PubMed Central - PubMed

Affiliation: Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. stefan.lang@uniklinik-freiburg.de.

ABSTRACT

Background: Corneal cross-linking is widely used to treat keratoconus. However, to date, only limited data from randomized trials support its efficacy.

Methods: The efficacy and safety of corneal cross-linking for halting progression of keratoconus were investigated in a prospective, randomized, blinded, placebo controlled, multicentre trial. Twenty-nine keratoconus patients were randomized in three trial centres. The mean age at inclusion was 28 years. Longitudinal changes in corneal refraction were assessed by linear regression. The best corrected visual acuity, surface defects and corneal inflammation were also assessed. These data were analysed with a multifactorial linear regression model.

Results: A total of 15 eyes were randomized to the treatment and 14 to the control group. Follow-up averaged 1098 days. Corneal refractive power decreased on average (+/-standard deviation) by 0.35 +/- 0.58 dioptres/year in the treatment group. The controls showed an increase of 0.11 +/- 0.61 dioptres/year. This difference was statistically significant (p = 0.02).

Conclusions: Our data suggest that corneal cross-linking is an effective treatment for some patients to halt the progression of keratoconus. However, some of the treated patients still progressed, whereas some untreated controls improved. Therefore, further investigations are necessary to decide which patients require treatment and which do not.

Trial registration: NCT00626717, Date of registration: February 20, 2008.

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Corneal refractive power for each patient over the time of the follow-up
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Fig2: Corneal refractive power for each patient over the time of the follow-up

Mentions: Four patients in the treatment group showed a slight steepening of their corneal topography. Eleven patients showed a slight flattening or remained stable. In the control group, eight patients showed steepening and six patients showed flattening of the simulated maximum K-reading (Table 1, Fig. 2). In the treatment group the corneal refractive power (Kmax) decreased in mean (+/−standard deviation) by 0.35 +/− 0.58 dioptres per year. The control-group showed an increase of 0.11 +/− 0.61 dioptres per year (Fig. 2). This difference was statistically significant (p = 0.02) in the multiple linear regression model. Considering our definition of progression, two patients in the placebo group and one patient in the treatment group showed a clinically significant progression. The corneal refractive power showed an increase of 1.5 dioptres per year in a 38-year-old patient.Fig. 2


Prospective, randomized, double-blind trial to investigate the efficacy and safety of corneal cross-linking to halt the progression of keratoconus.

Lang SJ, Messmer EM, Geerling G, Mackert MJ, Brunner T, Dollak S, Kutchoukov B, Böhringer D, Reinhard T, Maier P - BMC Ophthalmol (2015)

Corneal refractive power for each patient over the time of the follow-up
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4508968&req=5

Fig2: Corneal refractive power for each patient over the time of the follow-up
Mentions: Four patients in the treatment group showed a slight steepening of their corneal topography. Eleven patients showed a slight flattening or remained stable. In the control group, eight patients showed steepening and six patients showed flattening of the simulated maximum K-reading (Table 1, Fig. 2). In the treatment group the corneal refractive power (Kmax) decreased in mean (+/−standard deviation) by 0.35 +/− 0.58 dioptres per year. The control-group showed an increase of 0.11 +/− 0.61 dioptres per year (Fig. 2). This difference was statistically significant (p = 0.02) in the multiple linear regression model. Considering our definition of progression, two patients in the placebo group and one patient in the treatment group showed a clinically significant progression. The corneal refractive power showed an increase of 1.5 dioptres per year in a 38-year-old patient.Fig. 2

Bottom Line: This difference was statistically significant (p = 0.02).Therefore, further investigations are necessary to decide which patients require treatment and which do not.NCT00626717, Date of registration: February 20, 2008.

View Article: PubMed Central - PubMed

Affiliation: Eye Center, Albert-Ludwigs-University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. stefan.lang@uniklinik-freiburg.de.

ABSTRACT

Background: Corneal cross-linking is widely used to treat keratoconus. However, to date, only limited data from randomized trials support its efficacy.

Methods: The efficacy and safety of corneal cross-linking for halting progression of keratoconus were investigated in a prospective, randomized, blinded, placebo controlled, multicentre trial. Twenty-nine keratoconus patients were randomized in three trial centres. The mean age at inclusion was 28 years. Longitudinal changes in corneal refraction were assessed by linear regression. The best corrected visual acuity, surface defects and corneal inflammation were also assessed. These data were analysed with a multifactorial linear regression model.

Results: A total of 15 eyes were randomized to the treatment and 14 to the control group. Follow-up averaged 1098 days. Corneal refractive power decreased on average (+/-standard deviation) by 0.35 +/- 0.58 dioptres/year in the treatment group. The controls showed an increase of 0.11 +/- 0.61 dioptres/year. This difference was statistically significant (p = 0.02).

Conclusions: Our data suggest that corneal cross-linking is an effective treatment for some patients to halt the progression of keratoconus. However, some of the treated patients still progressed, whereas some untreated controls improved. Therefore, further investigations are necessary to decide which patients require treatment and which do not.

Trial registration: NCT00626717, Date of registration: February 20, 2008.

Show MeSH
Related in: MedlinePlus