Congenital CataractNCT06950619
Associations Between Dental Anomalies and Ocular, Cutaneous and Skin Appendages Features
A study testing Whole Genome Sequencing and Cephalometric tracing in people with Congenital Cataract and Tooth Abnormalities, run by University of Pavia at 2 sites in Italy.
Trial summary
Considering recent literature, it is possible to hypothesise a link between dental anomalies and ocular and/or cutaneous findings, given the existence of shared genetic and developmental mechanisms between these two anatomical areas. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Congenital Cataract, Tooth Abnormalities, Ocular Pathologies
- What is being tested?
- Whole Genome Sequencing and Cephalometric tracing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesItaly
- Study dates
- Feb 2026to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Supernumerary teeth
- oligodontia
- screw driver sharped incisors
- Hutchinson's teeth
- mulberry molars
- tooth agenesis
- congenital cataract, keratitis, keratoconus, corneal dystrophies, ectopia lentis, glaucoma, retinitis pigmentosa, coloboma and aniridia in probands or relatives
- skin appendages anomalies in probands or relatives
Who cannot join
- Previous orthodontic, restorative, endodontic, prosthetic and surgical treatment that could alter tooth morphology and position
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites
Unit of Medical Genetics, Department of Molecular Medicine, University of Pavia
Pavia, Lombardy, 27100
Edoardo Errichiello, PhD, edoardo.errichiello@unipv.it
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, 27100
Maurizio Pascadopoli, PhD, +39 0382516223, maurizio.pascadopoli01@universitadipavia.it
About this study
Official title: A Clinical Investigation Into the Co-occurrence of Dental Anomalies With Ocular and Cutaneous Features
Considering recent literature, it is possible to hypothesise a link between dental anomalies and ocular and/or cutaneous findings, given the existence of shared genetic and developmental mechanisms between these two anatomical areas. Both the eye and teeth develop from ectodermal and mesenchymal tissues, involving common molecular signalling pathways such as Wnt, BMP and PAX. Genetic variants affecting these pathways can therefore determine combined phenotypes, such as congenital cataracts associated with dental agenesis or enamel malformations. Some rare genetic syndromes, such as Nance-Horan syndrome and oculofacio-cardio-dental (OFCD) syndrome, support the hypothesis of a systemic correlation between odontogenesis and ocular development. In a previous study on congenital cataracts, nearly 10% of probands with variants in the BCOR, CWC27, IFIH1, NHS, and PAX6 genes had various dental abnormalities. Therefore, exploring the possible connection between eye and dental diseases may not only facilitate early and multidisciplinary diagnosis, but also open up new perspectives in genetic research and the development of personalised therapeutic approaches, for which whole genome sequencing (WGS) appears to be the first choice for investigating non-syndromic forms. Therefore, the current clinical study aims to identify variants in genes common to eye diseases and dental anomalies (agenesis, supernumerary teeth, Hutchinson's teeth, mulberry molars) in orthodontic patients over the age of 12 with dental anomalies who are about to begin orthodontic treatment or who are attending routine check-ups at the Orthodontics and Paediatric Dentistry Unit, Department of Clinical, Surgical, Diagnostic and Paediatrics Sciences at the University of Pavia who have a family history of ocular and cutaneous manifestations or presenting at the same time dental, ocular and/or cutaneous anomalies. Patients who are eligible will be invited to participate in the study. After signing the informed consent form, the Case Report Form will be completed to collect the data of interest for the study; previous medical reports will be asked to patients or parents/legal guardians in case of minors to ascertain ocular and cutaneous pathologies; a buccal swab will be taken to collect a DNA sample that will be analysed with Next Generation Sequencing. In addition, cephalometric evaluations will be performed if lateral teleradiographs will be available, if already performed in accordance with Good Clinical Practice for the purposes of orthodontic assessment of patients.
- Conditions
- Congenital Cataract, Tooth Abnormalities, Ocular Pathologies
- Being tested
- Whole Genome Sequencing, Cephalometric tracing
- Medical subject headings
- Tooth Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Genome SequencingGenetic
Genetic testing will be performed to find variants in genes involving congenital cataract and/or ocular diseases (keratitis, keratoconus, corneal dystrophies, ectopia lentis, glaucoma, retinitis pigmentosa, coloboma and aniridia) and dental anomalies (tooth agenesis, supernumerary teeth, Hutchinson teeth, mulberry molars). Cutaneous appendage anomalies will be also evaluated in clinical history for ascertaining ectodermal diplasia.
Cephalometric tracingOther
Cephalometric tracing will be performed on lateral cephalometric radiographs if present and not taken on purpose for the study
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic patients | Experimental | Patients fulfilling the inclusion criteria will undergo blood sampling Receives: Genetic: Whole Genome Sequencing; Other: Cephalometric tracing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of variants in common genes for dental anomalies, ocular diseases and cutaneous/skin appendages features
Whole Genome Sequencing will be used to find pathogenetic variants
Measured: Baseline
Secondary outcomes (9)
SNA angle
Angle between the sella, nasion and A point measured on lateral cephalometric radiograph
Measured: Baseline
SNB angle
Angle between the sella, nasion and B point measured on lateral cephalometric radiograph
Measured: Baseline
ANB angle
Angle between point A, the nasion and point B measured on lateral cephalometric radiograph
Measured: Baseline
SN plane
Plane between the sella point S and nasion point N measured on lateral cephalometric radiograph
Measured: Baseline
ANS-PNS plane
Bispinal plane traced between the anterior nasal spine (ANS) and the posterior nasal spine (PNS) measured on lateral cephalometric radiograph
Measured: Baseline
GoGn plane
Mandibular plane traced between Gonion and Gnathion points measured on lateral cephalometric radiograph
Measured: Baseline
Sella turcica length
Distance between the Tuberculum sellae (TS) and the dorsum sella measured on lateral cephalometric radiograph
Measured: Baseline
Sella turcica diameter
Distance between the Tuberculum Sellae (TS) and the farthest point on the inner wall of the sella measured on lateral cephalometric radiograph
Measured: Baseline
Sella turcica depth
The distance of a line dropped perpendicularly from the interclinoidal distance to the deepest point of the sella floor measured on lateral cephalometric radiograph
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study startFeb 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950619
- Sponsor's protocol ID
- 2025-DENTALOCULARANOMALIES
- Status last verified
- Nov 2025
- First submitted
- 21 Apr 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Publications
Lecca M, Mauri L, Gana S, Del Longo A, Morelli F, Nicotra R, Plumari M, Galli J, Sirchia F, Valente EM, Cavallari U, Mazza M, Signorini S, Errichiello E. Novel molecular, structural and clinical findings in an Italian cohort of congenital cataract. Clin Genet. 2024 Oct;106(4):403-412. doi: 10.1111/cge.14568. Epub 2024 Jun 5.
PubMed 38840272