Retinopathy of Prematurity - Visual Function and Retinal Structure

NCT07427719 | Not Yet Recruiting

• 1 other identifier: 927328
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common. In this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).

Conditions

Retinopathy of Prematurity (ROP); Prematurity Complications; Cerebral Visual Impairment; Visual Field Defect

Keywords

Retinopathy of Prematurity; Treatment; Laser; anti-vascular endothelial growth factor; Visual field defect; Cerebral visual impairment; Refractive errors; Prematurity

Outcome Measures

Primary Outcomes (5)

• Width of the foveal avascular zone

  Width of the foveal avascular zone in micrometers measured with optical coherence tomography angiography

  From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years

• Choroidal vascularity

  Choroidal vascularity in the macula measured with optical coherence tomography and with choroidal vascularity index in percent

  From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.

• Retinal nerve fiber layer thickness

  Retinal nerve fiber layer thickness in micrometers measured with optical coherence tomography

  From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.

• Length of persistent avascular retina

  Length of persistent avascular retina measured in millimeters using scanning laser ophthalmoscopy and fluorescein angiography

  From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.

• Width of the visual field

  Width of the visual field in degrees measured with Goldmann Perimetry

  From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.

Secondary Outcomes (2)

• Correlation between cerebral visual impairment and brain hemorrhages

  Neonatal period to time for data collection in the current study

• Visual acuity

  From date of treatment with either laser or A-VEGF until date of examination in the current study, with a maximum of 18 years.

Study Arms (4)

Laser treated

Subjects treated for ROP with laser of avascular retina

Control laser treated

Control subjects matched with subjects treated with laser

A-VEGF treated

Subjects treated for ROP with intravitreal injection of A-VEGF

Control A-VEGF treated

Control subjects matched with subjects treated with A-VEGF

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

* Group 1: patients treated for ROP with laser * Group 2: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 1) * Group 3: patients treated for ROP with injection of A-VEGF * Group 4: patients previously diagnosed with ROP but not treated (matched 1:1 with patients in group 3)

You may qualify if:

• Patients treated for ROP with either laser or injection of A-VEGF.
• Patients previously diagnosed with ROP but not treated for the condition.

You may not qualify if:

• Age below six years at date of examination.
• A developmental level not compatible with performing the study examinations.
• Patients born or treated outside Norway
• Known ocular or systemic disease that can give structural or functional changes in the retina.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0424, Norway

Location

Related Publications (31)

• Hamad AE, Moinuddin O, Blair MP, Schechet SA, Shapiro MJ, Quiram PA, Mammo DA, Berrocal AM, Prakhunhungsit S, Cernichiaro-Espinosa LA, Mukai S, Yonekawa Y, Ung C, Holz ER, Harper CA 3rd, Young RC, Besirli CG, Nagiel A, Lee TC, Gupta MP, Walsh MK, Khawly JA, Campbell JP, Kychenthal A, Nudleman ED, Robinson JE, Hartnett ME, Calvo CM, Chang EY. Late-Onset Retinal Findings and Complications in Untreated Retinopathy of Prematurity. Ophthalmol Retina. 2020 Jun;4(6):602-612. doi: 10.1016/j.oret.2019.12.015. Epub 2019 Dec 24.

  PMID: 32059986 BACKGROUND

• Lai TT, Yang CM, Hsieh YT, Yeh PT, Huang CW, Tsai CY. RATE OF AND TIME TO COMPLETE RETINAL VASCULARIZATION IN PREMATURE INFANTS AND ASSOCIATED FACTORS. Retina. 2023 Jan 1;43(1):102-110. doi: 10.1097/IAE.0000000000003627.

  PMID: 36201755 BACKGROUND

• Sternfeld A, Rahmani S, Rossen JL, Zhang DL, Li YD, Quan VL, Huang R, Yoon HH. Long-term retinal vasculature abnormalities following intravitreal bevacizumab for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2022 Jun;260(6):1915-1921. doi: 10.1007/s00417-021-05499-0. Epub 2021 Dec 1.

  PMID: 34851464 BACKGROUND

• Ling XC, Kang EY, Huang JL, Chou HD, Liu L, Lai CC, Chen KJ, Hwang YS, Wu WC. Persistent Vascular Anomalies in Retinopathy of Prematurity Children: Ultrawide-field Fluorescein Angiography Findings until School Age. Ophthalmol Sci. 2023 Feb 7;3(3):100281. doi: 10.1016/j.xops.2023.100281. eCollection 2023 Sep.

  PMID: 37113473 BACKGROUND

• Edmond JC, Foroozan R. Cortical visual impairment in children. Curr Opin Ophthalmol. 2006 Dec;17(6):509-12. doi: 10.1097/ICU.0b013e3280107bc5.

  PMID: 17065917 BACKGROUND

• Obata S, Matsumoto R, Iwasa M, Kakinoki M, Sawada O, Sawada T, Saishin Y, Ohji M. Visual field after anti-vascular endothelial growth factor therapy and laser treatment for retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3207-3213. doi: 10.1007/s00417-023-06227-6. Epub 2023 Sep 6.

  PMID: 37674073 BACKGROUND

• McLoone E, O'Keefe M, McLoone S, Lanigan B. Effect of diode laser retinal ablative therapy for threshold retinopathy of prematurity on the visual field: results of goldmann perimetry at a mean age of 11 years. J Pediatr Ophthalmol Strabismus. 2007 May-Jun;44(3):170-3. doi: 10.3928/0191-3913-20070301-10.

  PMID: 17542439 BACKGROUND

• Cryotherapy for Retinopathy of Prematurity Cooperative Group. Effect of retinal ablative therapy for threshold retinopathy of prematurity: results of Goldmann perimetry at the age of 10 years. Arch Ophthalmol. 2001 Aug;119(8):1120-5. doi: 10.1001/archopht.119.8.1120.

  PMID: 11483077 BACKGROUND

• Quinn GE, Dobson V, Hardy RJ, Tung B, Phelps DL, Palmer EA. Visual fields measured with double-arc perimetry in eyes with threshold retinopathy of prematurity from the cryotherapy for retinopathy of prematurity trial. The CRYO-Retinopathy of Prematurity Cooperative Group. Ophthalmology. 1996 Sep;103(9):1432-7. doi: 10.1016/s0161-6420(96)30487-9.

  PMID: 8841302 BACKGROUND

• Ingvaldsen SH, Morken TS, Austeng D, Dammann O. Visuopathy of prematurity: is retinopathy just the tip of the iceberg? Pediatr Res. 2022 Apr;91(5):1043-1048. doi: 10.1038/s41390-021-01625-0. Epub 2021 Jun 24.

  PMID: 34168272 BACKGROUND

• Kulmala M, Jorgensen APM, Aakvik KAD, Jussinniemi L, Benum SD, Ingvaldsen SH, Austeng D, Kajantie E, Evensen KAI, Majander A, Morken TS. Visual function in adults born preterm with very low birth weight-A two-country birth cohort study. Acta Ophthalmol. 2024 Feb;102(1):49-57. doi: 10.1111/aos.15683. Epub 2023 May 12.

  PMID: 37172142 BACKGROUND

• Balasubramanian S, Beckmann J, Mehta H, Sadda SR, Chanwimol K, Nassisi M, Tsui I, Marlow N, Jain S. Relationship between Retinal Thickness Profiles and Visual Outcomes in Young Adults Born Extremely Preterm: The EPICure@19 Study. Ophthalmology. 2019 Jan;126(1):107-112. doi: 10.1016/j.ophtha.2018.07.030. Epub 2018 Aug 6.

  PMID: 30092239 BACKGROUND

• Najjaran M, Zarei-Ghanavati S, Ostadimoghaddam H, Yekta A, Shoeibi N, Hemmati A, Abrishami M, Akhlaghi S, Ziaei M. Ocular Biometric and Optical Coherence Tomography Parameters in Former Preterm Children: A Cohort Study. J Ophthalmol. 2024 Sep 30;2024:2381582. doi: 10.1155/2024/2381582. eCollection 2024.

  PMID: 39376685 BACKGROUND

• Acar DE, Acar U, Tunay ZO, Arman A, Goksuluk D. Retinal choroidal and retinal nerve fiber layer thickness in former preterm and full-term infants aged 4 to 8 years. Int Ophthalmol. 2021 Mar;41(3):1071-1079. doi: 10.1007/s10792-020-01666-0. Epub 2021 Jan 2.

  PMID: 33387107 BACKGROUND

• Akerblom H, Holmstrom G, Eriksson U, Larsson E. Retinal nerve fibre layer thickness in school-aged prematurely-born children compared to children born at term. Br J Ophthalmol. 2012 Jul;96(7):956-60. doi: 10.1136/bjophthalmol-2011-301010. Epub 2012 May 8.

  PMID: 22569283 BACKGROUND

• Kumarakulasinghe ALB, Md Din N, Mohd Noh UK, Syed Zakaria SZ, Aung T, Mohd Khialdin S. Evaluation of Ocular Biometric and Optical Coherence Tomography Parameters in Preterm Children Without Retinopathy of Prematurity. Transl Vis Sci Technol. 2022 Mar 2;11(3):8. doi: 10.1167/tvst.11.3.8.

  PMID: 35258558 BACKGROUND

• Oruz O, Dervisogullari MS. Comparison of choroidal structural changes between term and preterm children with and without retinopathy of prematurity. Photodiagnosis Photodyn Ther. 2024 Feb;45:103901. doi: 10.1016/j.pdpdt.2023.103901. Epub 2023 Nov 22.

  PMID: 37996045 BACKGROUND

• Agrawal R, Gupta P, Tan KA, Cheung CM, Wong TY, Cheng CY. Choroidal vascularity index as a measure of vascular status of the choroid: Measurements in healthy eyes from a population-based study. Sci Rep. 2016 Feb 12;6:21090. doi: 10.1038/srep21090.

  PMID: 26868048 BACKGROUND

• Anderson MF, Ramasamy B, Lythgoe DT, Clark D. Choroidal thickness in regressed retinopathy of prematurity. Eye (Lond). 2014 Dec;28(12):1461-8. doi: 10.1038/eye.2014.207. Epub 2014 Oct 3.

  PMID: 25277303 BACKGROUND

• Prousali E, Dastiridou A, Ziakas N, Androudi S, Mataftsi A. Choroidal thickness and ocular growth in childhood. Surv Ophthalmol. 2021 Mar-Apr;66(2):261-275. doi: 10.1016/j.survophthal.2020.06.008. Epub 2020 Jul 4.

  PMID: 32634443 BACKGROUND

• Shao Z, Dorfman AL, Seshadri S, Djavari M, Kermorvant-Duchemin E, Sennlaub F, Blais M, Polosa A, Varma DR, Joyal JS, Lachapelle P, Hardy P, Sitaras N, Picard E, Mancini J, Sapieha P, Chemtob S. Choroidal involution is a key component of oxygen-induced retinopathy. Invest Ophthalmol Vis Sci. 2011 Aug 5;52(9):6238-48. doi: 10.1167/iovs.10-6742.

  PMID: 21546530 BACKGROUND

• Czeszyk A, Hautz W, Jaworski M, Bulsiewicz D, Czech-Kowalska J. Morphology and Vessel Density of the Macula in Preterm Children Using Optical Coherence Tomography Angiography. J Clin Med. 2022 Feb 28;11(5):1337. doi: 10.3390/jcm11051337.

  PMID: 35268428 BACKGROUND

• Zhao J, Wu Z, Lam W, Yang M, Chen L, Zheng L, Zhang F, Zeng J, Wang J, Zhang G. Comparison of OCT angiography in children with a history of intravitreal injection of ranibizumab versus laser photocoagulation for retinopathy of prematurity. Br J Ophthalmol. 2020 Nov;104(11):1556-1560. doi: 10.1136/bjophthalmol-2019-315520. Epub 2020 Feb 12.

  PMID: 32051137 BACKGROUND

• Jabroun MN, AlWattar BK, Fulton AB. Optical Coherence Tomography Angiography in Prematurity. Semin Ophthalmol. 2021 May 19;36(4):264-269. doi: 10.1080/08820538.2021.1893760. Epub 2021 Mar 9.

  PMID: 33689582 BACKGROUND

• Ingvaldsen SH, Moljord K, Grotting A, Omland PM, Dammann O, Austeng D, Morken TS. Retinal structure and visual pathway function at school age in children born extremely preterm: a population-based study. BMC Ophthalmol. 2023 Jul 1;23(1):296. doi: 10.1186/s12886-023-03055-4.

  PMID: 37393251 BACKGROUND

• Bowl W, Bowl M, Schweinfurth S, Holve K, Knobloch R, Stieger K, Andrassi-Darida M, Lorenz B. OCT Angiography in Young Children with a History of Retinopathy of Prematurity. Ophthalmol Retina. 2018 Sep;2(9):972-978. doi: 10.1016/j.oret.2018.02.004. Epub 2018 Jul 20.

  PMID: 31047230 BACKGROUND

• Balaratnasingam C, Chae B, Remmer MH, Gomez E, Suzuki M, Engelbert M, Spaide RF. The Spatial Profile of Macular Pigments Is Related to the Topological Characteristics of the Foveal Avascular Zone. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):7859-65. doi: 10.1167/iovs.15-17532.

  PMID: 26658507 BACKGROUND

• Provis JM, Hendrickson AE. The foveal avascular region of developing human retina. Arch Ophthalmol. 2008 Apr;126(4):507-11. doi: 10.1001/archopht.126.4.507.

  PMID: 18413520 BACKGROUND

• Maleita D, Serras-Pereira R, Passos I, Elisa-Luis M, Alves M, Papoila AL, Brito C, Cunha JP, Tavares Ferreira J. Retinal structural changes in preterm children without retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2021 Apr;259(4):1025-1033. doi: 10.1007/s00417-020-04986-0. Epub 2020 Nov 4.

  PMID: 33146830 BACKGROUND

• Fiess A, Janz J, Schuster AK, Kolb-Keerl R, Knuf M, Kirchhof B, Muether PS, Bauer J. Macular morphology in former preterm and full-term infants aged 4 to 10 years. Graefes Arch Clin Exp Ophthalmol. 2017 Jul;255(7):1433-1442. doi: 10.1007/s00417-017-3662-5. Epub 2017 Apr 25.

  PMID: 28439729 BACKGROUND

• Wendel K, Aas MF, Gunnarsdottir G, Rossholt ME, Bratlie M, Nordvik T, Landsend ECS, Fugelseth D, Domellof M, Pripp AH, Stiris T, Moltu SJ. Effect of arachidonic and docosahexaenoic acid supplementation on respiratory outcomes and neonatal morbidities in preterm infants. Clin Nutr. 2023 Jan;42(1):22-28. doi: 10.1016/j.clnu.2022.11.012. Epub 2022 Nov 17.

  PMID: 36473425 RESULT

MeSH Terms

Conditions

Retinopathy of Prematurity; Blindness, Cortical; Refractive Errors; Premature Birth

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Erlend Christoffer Sommer Landsend, M.D., Ph.D.

  Oslo University Hospital

  STUDY CHAIR

Central Study Contacts

Erlend Christoffer Sommer Landsend, M.D., Ph.D.

CONTACT

0047 91 50 27 70; erllan@ous-hf.no

Amanda Schjetlein, M.D.

CONTACT

0047 91 50 27 70; amasch@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant and researcher

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

NO (1)