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Not yet recruitingNCT07427719Updated Nov 10, 2026

Retinopathy of Prematurity - Visual Function and Retinal Structure

An observational study in Retinopathy of Prematurity (ROP), Prematurity Complications and Cerebral Visual Impairment, sponsored by Oslo University Hospital. Not yet recruiting at 1 site in Norway. Open to participants aged 6 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Oslo University Hospital · Observational

Updated Nov 10, 2026Start date movedPrimary completion movedGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
140
Ages
6 Years to 20 Years
Sex
All
01

Study 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).

Read the detailed description

Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). The risk of ROP increases with lower gestational age and birth weight of the child. In a child born pre-term the blood vessels in the retina may not be fully developed. New - but unstructured - vessels could grow up from the retina and lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) into the eye has become more common.

In this study, the researchers aim to explore whether treatment of ROP affects visual function and retinal development. To investigate 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).

The participants will undergo a comprehensive eye examination, including imaging of the retina, visual field testing, and biometric measurements. Their parents will also answer questions regarding cerebral visual impairment.

Results from the group not treated for ROP will be compared to the treated subjects. Data will also be correlated with non-ocular parameters, such at gestational age, birth weight and brain hemorrhages.

02

Conditions studied

  • 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
03

In context

Retinopathy of Prematurity

169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.

This study's planned enrollment of 140 is below the median of 175 across 57 observational studies indexed under Retinopathy of Prematurity.

Browse Retinopathy of Prematurity studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 834 studies on the registry; 149 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

  • 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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Width of the foveal avascular zone

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

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

  2. Choroidal vascularity

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

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

  3. Retinal nerve fiber layer thickness

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

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

  4. Length of persistent avascular retina

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

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

  5. Width of the visual field

    Width of the visual field in degrees measured with Goldmann Perimetry

    Time frame: 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

  1. Correlation between cerebral visual impairment and brain hemorrhages

    Correlation between scores for cerebral visual impairment at time of the study and brain hemorrhages in neonatal period

    Time frame: Neonatal period to time for data collection in the current study

  2. Visual acuity

    Visual acuity measured with LogMAR.

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

07

Study locations

1 site
08

References and documents

Publications

  • 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. PubMed 32059986 ↗
  • 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. PubMed 36201755 ↗
  • 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. PubMed 34851464 ↗
  • 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. PubMed 37113473 ↗
  • Edmond JC, Foroozan R. Cortical visual impairment in children. Curr Opin Ophthalmol. 2006 Dec;17(6):509-12. doi: 10.1097/ICU.0b013e3280107bc5. PubMed 17065917 ↗
  • 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. PubMed 37674073 ↗
  • 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. PubMed 17542439 ↗
  • 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. PubMed 11483077 ↗
  • 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. PubMed 8841302 ↗
  • 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. PubMed 34168272 ↗
  • 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. PubMed 37172142 ↗
  • 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. PubMed 30092239 ↗
  • 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. PubMed 39376685 ↗
  • 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. PubMed 33387107 ↗
  • 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. PubMed 22569283 ↗
  • 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. PubMed 35258558 ↗
  • 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. PubMed 37996045 ↗
  • 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. PubMed 26868048 ↗
  • 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. PubMed 25277303 ↗
  • 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. PubMed 32634443 ↗
  • 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. PubMed 21546530 ↗
  • 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. PubMed 35268428 ↗
  • 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. PubMed 32051137 ↗
  • 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. PubMed 33689582 ↗
  • 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. PubMed 37393251 ↗
  • 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. PubMed 31047230 ↗
  • 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. PubMed 26658507 ↗
  • 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. PubMed 18413520 ↗
  • 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. PubMed 33146830 ↗
  • 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. PubMed 28439729 ↗
  • 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. PubMed 36473425 ↗

Individual participant data

Plan to share: Undecided — Awaits allowance to share IPD from the Regional committees for medical and health research ethics.

09

Updates

1 registry update since Sep 25, 2026
Start date
Apr 1, 2026→Jan 1, 2027
Nov 10, 2026
Primary completion
Jan 1, 2027→Jan 1, 2028
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Start date Apr 1, 2026→Jan 1, 2027
    Primary completion Jan 1, 2027→Jan 1, 2028

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07427719
Responsible party
Erlend Christoffer Sommer Landsend (Senior consultant and researcher, Oslo University Hospital) — Principal investigator
First posted
Feb 23, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2028 (estimated)
Completion
Jun 1, 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Erlend Christoffer Sommer Landsend, M.D., Ph.D.
Contact
erllan@ous-hf.no
0047 91 50 27 70
Amanda Schjetlein, M.D.
Contact
amasch@ous-hf.no
0047 91 50 27 70
Erlend Christoffer Sommer Landsend, M.D., Ph.D.
study chair · Oslo University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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