Follow-up after surgical treatment for intermittent claudication (FASTIC): a study protocol for a multicentre randomised controlled clinical trial

In a double blind randomised controlled clinical trial the effect of antiplatelet agents (aspirin 330 mg × 3 × day) or in combination with dipyridamole (75 mg 3 × day) versus placebo, was tested in 475 patients with early diabetic retinopathy. Patients were follewed fourmonthly for 3 years. Ophtalmological examinations were carried out initially and at yearly intervals. The assessment of retinopathy was based on changes in the number of microaneurysms (MA) present in the macular field as seen on fluorescein angiograms over a period of three years. Forty one patients did not complete the study. Among the others at least three readable initial and yearly angiograms were available on 420 patients who had a 3 year follow up (266 insulin treated and 154 non insulin treated). The results are based on these patients.It is concluded that either Aspirin alone or in conjunction with dipyridamole significantly slows down the progression of MA evolution in early diabetic retinopathy. Because of the very small, although significant changes, the clinical relevance of these drugs has not been established.

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Visual and refractive outcomes and complications in femtosecond laser-assisted versus conventional phacoemulsification cataract surgery: findings from a randomised, controlled clinical trial

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2019-314548 ◽

2020 ◽

pp. bjophthalmol-2019-314548

Author(s):

Daliya Dzhaber ◽

Osama M Mustafa ◽

Fares Alsaleh ◽

Yassine J Daoud

Keyword(s):

Clinical Trial ◽

Visual Acuity ◽

Femtosecond Laser ◽

Cataract Surgery ◽

Controlled Clinical Trial ◽

Distance Visual Acuity ◽

Refractive Outcomes ◽

Randomised Controlled Clinical Trial ◽

Randomised Controlled

Background/aimTo compare visual and refractive outcomes, changes in intraocular pressure (IOP), and complications of femtosecond laser-assisted cataract surgery (FLACS) to conventional phacoemulsification surgery (CPS) in paired eyes from the same patients.MethodsThis is a secondary analysis of an intraindividual, randomised, controlled clinical trial including 110 paired eyes from 55 patients that were randomised into either FLACS or CPS groups. Outcomes were recorded at baseline and postoperatively during a 3-month follow-up period.ResultsUncorrected distance visual acuity and corrected distance visual acuity were similar between FLACS and CPS over the follow-up period (p>0.05). The mean absolute refractive error was not significantly different between the two groups at postoperative month 1 (POM1) (0.3±0.2 D in FLACS vs 0.4±0.3 D in CPS, p=0.18) and month 3 (POM3) (0.3±0.3 D in FLACS vs 0.3±0.3 D in CPS, p=0.71). IOP was statistically higher in the FLACS group on postoperative day 1 (20.6±5.7 mm Hg for FLACS and 18.0±4.9 mm Hg for CPS, p=0.01). However, it was similar between the two groups subsequently (p>0.05). Intraoperatively, one case of posterior capsular block syndrome was observed in the FLACS group. Postoperatively, one case of newly developed glaucoma was observed in the FLACS group and one case of retinal tears in the CPS group.ConclusionThe 3-month postoperative refractive and visual outcomes were comparable between FLACS and CPS in paired eyes from the same patients. Complication rate was low in the study population.

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