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Status unknownNCT06545305Updated Aug 13, 2024

Incidence and Risk Factors of Ocular Complications Among Patients With Homocystinuria

An observational study in Complications, sponsored by King Fahad Armed Forces Hospital. Status unknown at 1 site in Saudi Arabia. Open to participants aged 20 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by King Fahad Armed Forces Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
6
Ages
20 Years to 30 Years
Sex
All
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Study summary

Background: Cysteine beta-synthase (CBS) deficiency, often known as classic homocystinuria (HCU), is an uncommon inborn mistake in methionine metabolism. Developmental delay, intellectual incapacity, skeletal and vascular symptoms, and ocular abnormalities are possible main clinical characteristics.

Objective: This study sought to describe the ocular anomalies that King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia, HCU patients presented with between 2018 and 2022.

Read the detailed description

This retrospective research included 6 HCU patients. Demographic and clinical characteristics of patients as age, gender, comorbidities were collected. Relevant clinical and ophthalmic assessments, like visual acuity, fundus examination findings, complications and type of surgery were also reported

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Conditions studied

  • Complications

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Keywords

  • ocular complications
  • high myopia
  • Saudi Arabia
  • Classic Homocystinuria
  • Ectopia lentis
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In context

Homocystinuria

21 studies on the registry are indexed under Homocystinuria; 5 are open to participants now.

Browse Homocystinuria studies →

Lead sponsor

King Fahad Armed Forces Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

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

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Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patient's records gathered from outpatient internal medicine and pediatric encounters. Six patients met study inclusion criteria. Demographic and clinical characteristics of patients were collected. Relevant clinical and ophthalmic assessments, as visual acuity, fundus examination, complications and surgery type were also obtained. Visual acuity, in-clinic dilated fundus examination, optical coherence tomography (OCT) angiography, macular OCT scan, and fundus photography were components of ophthalmic examinations. Fundus examination involved retinal inspection, visual acuity measured using tumbling E chart.

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

  • All patients from all age groups who were diagnosed with homocystinuria between 2018 and 2022 were included, regardless of whether the diagnosis was made biochemically (by exhibiting hyperhomocysteinaemia and hypermethioninaemia) or genetically (by discovering biallelic pathogenic mutations in the CBS gene)

Exclusion criteria

Exclusion Criteria:

  • Patients with incomplete investigations for various reasons
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
6 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with Homocystinuria

    Homocystinuria patients with Ocular complications

    Procedure: Lensectomy and vitrectomy

Interventions

  • ProcedureLensectomy and vitrectomy

    Corrections

    Also known as: Scleral fixation, Grice green procedure

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What researchers measure

Primary outcomes

  1. Autoref reading

    Refractory errors

    Time frame: After one year

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Study locations

1 site
  • King Fahad Armed Forces Hospital
    Jeddah, 22522, Saudi Arabia
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References and documents

Individual participant data

Plan to share: Undecided — The data available with principal investigator when needed

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2024 to primary completion in Jul 2024, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2024
First posted
Aug 9, 2024
StartActual
Jan 1, 2024
Primary completionActual
Jul 1, 2024
CompletionEst.
Aug 30, 2024
Last update
Aug 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06545305
Lead sponsor
King Fahad Armed Forces Hospital
Responsible party
Hassan A. Ahmed (Residence, King Fahad Armed Forces Hospital) — Principal investigator
First posted
Aug 9, 2024
Start date
Jan 1, 2024
Primary completion
Jul 1, 2024
Completion
Aug 30, 2024 (estimated)
Last update
Aug 13, 2024

Study contacts

Hassan A Ahmed, MS
principal investigator · Pediatric Department, King Salman Medical city-Maternity and Children, Medina, Saudi Arabia

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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