NanophthalmosNCT03748732
Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes
A study testing sclerectomy in people with Nanophthalmos, run by Rafic Hariri University Hospital at 1 site in Lebanon.
Trial summary
Purpose: To describe an extensive scleral excision technique to treat or prevent uveal effusion in nanophthalmic eyes. Design: Prospective interventional case series. Methods: Setting: Institutional. Patient Population: Consecutive patients with nanophthalmos were operated on by one surgeon. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nanophthalmos
- What is being tested?
- sclerectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2011to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: To describe an extensive scleral excision technique to treat or prevent uveal effusion in nanophthalmic eyes.
Design: Prospective interventional case series.
Methods:
- Setting: Institutional.
- Patient Population: Consecutive patients with nanophthalmos were operated on by one surgeon.
- Intervention Procedure: A single, 90% thickness scleral window extending from immediately behind the extraocular muscle insertions to the vortex veins was performed for 3 and 1/4 quadrants as a circumferential strip.
- Main Outcome Measure: Resolution or prevention of uveal effusion.
Read the detailed description
Surgical Technique All surgeries were performed under general anesthesia by one surgeon (AMM). Because the majority of the patients were young with narrow palpebral fissures and very deep set globes in small orbits, special surgical techniques were required. Lateral canthotomy was performed on all patients except for the first. Limbal 360o conjunctival peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0 silk suture. Scleral dissection was performed from immediately behind to the muscle insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ¼ quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior oblique muscle.
- Conditions
- Nanophthalmos
- Being tested
- sclerectomy
- Keywords
- uveal effusion
- Medical subject headings
- Microphthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sclerectomyProcedure or surgery
Also called maximal scleral excision
scleral flap
What is being measured
The primary outcome is the main question the study is designed to answer.
resolution of uveal effusion
disappearence of uveal effusion by OCT
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Jan 2011
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NanophthalmosStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- surgery
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rafic Hariri University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Mansour, MD, Clinical Professor, AUB, Rafic Hariri University Hospital
- Investigators
- Ahmad Mansour, MD, Study chair, Rafic Hariri University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748732
- Sponsor's protocol ID
- RaficHaririUHAMM
- Status last verified
- Nov 2018
- First submitted
- 18 Nov 2018
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: if part of collaboration, we will share the data
Publications
Carricondo PC, Andrade T, Prasov L, Ayres BM, Moroi SE. Nanophthalmos: A Review of the Clinical Spectrum and Genetics. J Ophthalmol. 2018 May 9;2018:2735465. doi: 10.1155/2018/2735465. eCollection 2018.
PubMed 29862063Mansour A, Stewart MW, Shields CL, Hamam R, Abdul Fattah M, Sheheitli H, Mehanna CJ, Yassine S, Chahine H, Keaik M, Maalouf F, Jaroudi M. Extensive circumferential partial-thickness sclerectomy in eyes with extreme nanophthalmos and spontaneous uveal effusion. Br J Ophthalmol. 2019 Dec;103(12):1862-1867. doi: 10.1136/bjophthalmol-2018-313702. Epub 2019 Mar 15.
PubMed 30877130
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extensive Circumferential Partial Thickness Sclerectomy in Nanophthalmic Eyes
- ClinicalTrials.gov ID
- NCT03748732
- Acronym / sponsor ID
- RaficHaririUHAMM
- Conditions
- Nanophthalmos
- Keywords
- uveal effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rafic Hariri University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To describe an extensive scleral excision technique to treat or prevent uveal effusion in nanophthalmic eyes.
Design: Prospective interventional case series.
Methods:
- Setting: Institutional.
- Patient Population: Consecutive patients with nanophthalmos were operated on by one surgeon.
- Intervention Procedure: A single, 90% thickness scleral window extending from immediately behind the extraocular muscle insertions to the vortex veins was performed for 3 and 1/4 quadrants as a circumferential strip.
- Main Outcome Measure: Resolution or prevention of uveal effusion.
Detailed description
Surgical Technique All surgeries were performed under general anesthesia by one surgeon (AMM). Because the majority of the patients were young with narrow palpebral fissures and very deep set globes in small orbits, special surgical techniques were required. Lateral canthotomy was performed on all patients except for the first. Limbal 360o conjunctival peritomy was followed by securing of each rectus muscles with a modified muscle hook and 2-0 silk suture. Scleral dissection was performed from immediately behind to the muscle insertions posterior to the vortex veins. A 90% depth scleral window was excised over 3 and ¼ quadrants, excluding 3/4 of the superior temporal quadrant to avoid damaging the superior oblique muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- surgery
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sclerectomyAlso: maximal scleral excisionscleral flap | Procedure or surgery | – |
Primary outcome
resolution of uveal effusion
Time frame: 1 month
disappearence of uveal effusion by OCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Results publication: PubMed 29862063Carricondo PC, Andrade T, Prasov L, Ayres BM, Moroi SE. Nanophthalmos: A Review of the Clinical Spectrum and Genetics. J Ophthalmol. 2018 May 9;2018:2735465. doi: 10.1155/2018/2735465. eCollection 2018.
- Derived from this study: PubMed 30877130Mansour A, Stewart MW, Shields CL, Hamam R, Abdul Fattah M, Sheheitli H, Mehanna CJ, Yassine S, Chahine H, Keaik M, Maalouf F, Jaroudi M. Extensive circumferential partial-thickness sclerectomy in eyes with extreme nanophthalmos and spontaneous uveal effusion. Br J Ophthalmol. 2019 Dec;103(12):1862-1867. doi: 10.1136/bjophthalmol-2018-313702. Epub 2019 Mar 15.
- Individual participant dataSharing planned: Undecided. if part of collaboration, we will share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Mansour, MD study chair
Rafic Hariri University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sclerectomy in people with Nanophthalmos, run by Rafic Hariri University Hospital at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resolution of uveal effusion (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03748732, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.