DEPARTMENT OF OPHTALMOLOGY

INTRODUCTION

The department is the only Priority III level ophthalmology care facility in the county. It carries out patient care for the county and the region. In addition to diagnosing general ophthalmic diseases, our specialists treat targeted groups of patients in the outpatient unit. Our inpatient unit has 15 beds. The number of patients in our
outpatient department is 49,000 people annually. We perform 3,500 surgical interventions every year.

The main profiles of our inpatient and outpatient units are ocular surface diseases, corneal dystrophies, glaucoma, vascular pathologies, diabetes, age-related macular degeneration, pediatric ophthalmology, endocrine orbitopathy and ophthalmic oncology.
We also run one-day ophthalmic surgical interventions. Our surgical interventions are anterior and posterior segment surgeries such as keratoplasty, cataract surgery, glaucoma surgery, vitrectomy, aesthetic and reconstructive plastic surgery.

The staff has 10 years of experience in clinical trials. The most frequently investigated
ophthalmic diseases in clinical trials are dry eye syndrome, glaucoma, diabetic retinopathy
and age-related macular degeneration.

Management
Director:
Prof. Dr. Csutak Adrienne
University Professor

Deputy Director:
Dr. Tóthné Dr. Judit Mária Vékási
Chief Clinical Physician

Deputy Director for Nursing
Edit Káptalan

Business Administrator:
Tamásné Kovács

Personnel Administrator
Mária Horváth Soványné

Secretary for Director:
Eszter Szonntag

Number of clinical trial investigators with Good Clinical Practice (GCP) certificate: 1
Number of clinical trial doctors with Good Clinical Practice (GCP) certificate: 12
Number of specialist doctors with Clinical Pharmacology certificate: 0

EQUIPMENT FOR CLINICAL TRIALS

ETDRS board (Lighthouse Distance Visual Acuity Test – Second Edition)
Anterior segment photo slit lamp (Topcon + Zotac 4K UltraHD)
Posterior segment photo (Topcon TRC-501 X)
OCT (Topcon 3D OCT-2000 FA plus)
Automatic perimeter (Zeiss Humphrey Field Analyzer 3)
Pachymeter (Heidelberg Engineering – IOP AC Advacned)
In vivo corneal confocal microscope (Heidelberg HRT II)
Specular microscope (NIDEK CEM-530)
Orbscan (Bausch&Lomb Orbscan II)
UBM, UH-Bsan (Aviso Quantel Medical)
Digital blood pressure monitor (Omron M2)
Personal weight scales (Joycare JC-387

REFERENCE CLINICAL TRIALS

	Protocol Identifier	Name of Study	Principal Investigator
1.	LT2347	2015 - OAG/OHT Study	Prof. Dr. Csutak Adrienne
2.	LT1580-301	2016 – Dry Eye Disease Study	Prof. Dr. Csutak Adrienne
3.	0240-0024	2017- Open angle glaucoma (OAG) Study	Prof. Dr. Csutak Adrienne
4.	LT4030-201	2018- Open angle glaucoma Study	Prof. Dr. Csutak Adrienne
5.	LT4032-301	2020- Glaucoma study	Prof. Dr. Csutak Adrienne
6.	SB15-3001	2020 – wAMD study	Prof. Dr. Csutak Adrienne
7.	REC0559-B-001	2020 - Neurotrophic keratitis	Prof. Dr. Csutak Adrienne
8.	LT4030-301	2021 - Glaucoma study	Prof. Dr. Csutak Adrienne
9.	OPT-302-1005	2021 - AMD study	Prof. Dr. Csutak Adrienne
10.	ALT-L9-03	2022 - wetAMD study	Prof. Dr. Csutak Adrienne
11.	INTAS0504	2022 - wetAMD study	Prof. Dr. Csutak Adrienne
12.	HLX01-O-wAMD	2022 - vetAMD study	Prof. Dr. Csutak Adrienne
13.	OT_101_001	2022 - Myopia study	Prof. Dr. Csutak Adrienne
14.	IMVT-1401-3202	2023	Prof. Dr. Csutak Adrienne
15.	IMVT-1401-3203	2023	Prof. Dr. Csutak Adrienne

OUR PUBLICATIONS:

Non inferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension.
Aptel F, Pfeiffer N, Schmickler S, Clarke J, Lavín-Dapena C, Moreno-Montañés J, Żarnowski T, Csutak A, Jugaste T, Volksone L, Astakhov YS, Coupier L, Nordmann JP, Stalmans I; T2347 Study Group; J Glaucoma, 2019 Jun ;28(6):498-506. doi:10.1097/IJG.0000000000001248, PMID: 31166287

A randomized clinical trial comparing three fixed combinations of bimatoprost with timolol in patients with open-angle glaucoma or ocular hypertension.

Mrukwa-Kominek E, Misiuk-Hojlo M, Csutak A, Stalmans I, Garhofer G.Curr Med Res Opin. 2023 May;39(5):775-783. doi: 10.1080/03007995.2023.2197496. Epub 2023 Apr 17.PMID: 37013445 Clinical Trial.

Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial.

Woo SJ, Bradvica M, Vajas A, Sagong M, Ernest J, Studnicka J, Veith M, Wylegala E, Patel S, Yun C, Orski M, Astakhov S, Tóth-Molnár E, Csutak A, Enyedi L, Kim T, Oh I, Jang H, Sadda SR.JAMA Ophthalmol. 2023 Jul 1;141(7):668-676. doi: 10.1001/jamaophthalmol.2023.2260.PMID: 37289448 Free PMC article. Clinical Trial.

Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocular Hypertension.

Aptel F, Pfeiffer N, Schmickler S, Clarke J, Lavín-Dapena C, Moreno-Montañés J, Żarnowski T, Csutak A, Jugaste T, Volksone L, Astakhov YS, Coupier L, Nordmann JP, Stalmans I; T2347 Study Group.J Glaucoma. 2019 Jun;28(6):498-506. doi: 10.1097/IJG.0000000000001248.PMID: 31166287 Clinical Trial.

PRINCIPAL INVESTIGATORS

Prof. Dr. Csutak Adrienne

SCIENTIFIC DEGREE	PhD, Med. habil, MTA Doctor
POSITION	University Professor
QUALIFICATIONS	Ophthalmology examination
SCIENTIFIC INTEREST	Ophthalmology: tear film tests, refractive surgery, glaucoma, diabetes / diabetic retinopathy Basic research: tear research - in relation to refractive surgery, diabetes and neurodegenerative diseases and age-related changes (glaucoma, Alzheimer's, AMD)
REFERENCE CLINICAL TRIALS	2018 - A prospective, double-masked, randomized, multicenter, active-controlled, parallel-group, 6-month study assessing the safety and ocular hypotensive efficacy of PG324 Ophthalmic Solution compared to GANFORT® (bimatoprost 0.03%/timolol 0.5%) Ophthalmic Solution in subjects with elevated intraocular pressure. Department of Ophthalmology, University of Debrecen Principal Investigator, Aerie PG324-CS303 (Mercury 3) 2018 - Efficacy and safety assessment of T4030 eyedrops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients. Department of Ophthalmology, University of Debrecen Principal investigator, THEA LT 4030-201 2017 - Open angle glaucoma (OAG) Study. UDFM Department of Ophthalmology, IV phase. Sub Investigator. Santen (0240-0024) 2016 – Dry Eye Disease Study, UDFM Department of Ophthalmology, III phase, Principal Investigator, Laboratories Théa (LT1580-301) 2015 - OAG/OHT Study, UDFM Department of Ophthalmology, III phase, Principal Investigator, Laboratories Théa (LT2347) 2015 - Open angle glaucoma/ Ocular Hyper Tension (OAG/OHT) Study, UDFM Department of Ophthalmology, III phase, Sub Investigator, Allergan Artemis Study (192024-091) 2009 - Alzheimer Pilot Study Rec. Reference Number 09/H0710/10 Moorfields Eye Hospital, Sub Investigator 2009 – Reykjavik Eye Study 12 year follow-up OPTOS study PETT1010 Moorfields Eye Hospital Sub Investigator
AVAILABLE FOR PERFORMING CLINICAL TRIALS	Phase 2-4

STUDY TEAM

Study Coordinators

Our department has a study coordinator. We carry out clinical trials also by using the study coordinators of the Coordination Centre for Clinical Trials (KVKK).

Number of study coordinators with master degree (MSc): 0
Number of study coordinators with bachelor degree (BSc): 0
Number of study coordinators with further education degree: 1

Name	Phone	E-mail
Eszter Szonntag Bércesné	+36 72 504 210 / 33600 mellék	szonntag.eszter@pte.hu

Study Nurses

Our department has 5 study nurses.

Number of study nurses with master degree (MSc): 0
Number of study nurses with bachelor degree (BSc): 1
Number of study nurses with further education degree: 4

Name	Phone	E-mail
Anikó Sebestyén	+36 72 504 210 / 33625	sebestyen.aniko@pte.hu
Zsoltné Rékai	+36 72 504 210 / 33625	rekai.zsoltne@pte.hu
Anita Meződi Pántyáné	+36 72 504 210 / 33610	mezodi.anita@pte.hu
Gabriella Ney	+36 72 504 210 / 33619	rozsahegyi.zoltanne@pte.hu
Beáta Pinterics Tóthné	+36 72 504 210 / 33627	pinterics.beata@pte.hu

Created: 10/03/2019
Last updated: 30.10.2019.