Cystoid Macular Edema (CME) following prostaglandin analogue use after uncomplicated cataract surgery in glaucoma patients

To evaluate the effect of post-operative latanoprost administration on central macular thickness (CMT) after uncomplicated cataract surgery in glaucoma patients

Two-arm parallel group randomized trial with blinded outcome assessment. Randomization was centralized and computerized with concealed randomization sequence carried out at an external site

The study was conducted at Farabi Eye Hospital (Tehran University of Medical Sciences, Tehran, Iran). Patients without any risk factor or abnormality such as cystic changes in the macula in pre-op OCT were included for allocation. Patients were allocated into two groups; In the first group, on postoperative day 1, patients continued receiving latanoprost and other antiglaucoma topical agents to control the IOP. In the second group, on postoperative day 1, latanoprost was discontinued, and patients received any other antiglaucoma topical agents to control the IOP. All surgeries and post-operative examinations were done by the same expert cataract surgeon (GH. F.). Patients were aware of the allocation, while surgeon/examiner (GH. F.), outcome assessor/analyst (M.Y.) were masked to the patient allocation which was done by M.M.

Glaucoma patients treating with latanoprost; who need cataract surgery; and had no other risk factors for the development of pseudophakic macular edema; and with no abnormality in pre-operative optical coherence tomography (OCT) were included.

Patients were allocated into two groups; continue latanoprost and discontinue latanoprost.

Main outcome was defined as central macular thickness (CMT) change from baseline measured by OCT imaging. Secondary outcomes were incidence of clinical cystoid macular edema, incidence of significant increase in CMT, visual acuity, IOP, and number of antiglaucoma medications.

Vice chancellor for research, Tehran University of Medical Sciences

A computer-based program (Excel® Microsoft Office software version 2016) to assign our samples to the two groups was used. The randomization used was block permutated randomization with the random block size of 2,4 and 6. The random sequence obtained by a biostatistician and it was concealed from the research group by coloring the background of cells in Excel datasheet. Whenever each new patient was a candidate for allocation, one author (M.M) uncolored the devoted cell and allocated the patient according to the written number.

The design of the RCT was single-masked. Patients were aware of the allocation, while surgeon/examiner (GH.F.), outcome assessor/analyst (M.Y.) were masked to the patient allocation which was done by M.M.

Not published due to Farabi Eye Research department guidelines.

The study protocol and informed consent will be shared privately, but a report of the study will be shared in public. Depending on the request, all data may be shared.

After completion of the study, for 12 months.

Just for academic researchers.

Just for scientific and research purposes.

Please send an e-mail with relevant content to corresponding author: m-mirghorbani@razi.tums.ac.ir Seyed Masoud Mirghorbani Resident of Ophthalmology Farabi Eye Hospital, Qazvin sq, South Kargar st, Tehran +982155400003

Anyone who needs detailed information on study protocol and informed consent can e-mail to the corresponding author and request for the data. The request will be evaluated in a few weeks.