CataractNCT04208633
Correlation Between Sulcus Anatomy and Other Parameters After Horizontal & Vertical Intraocular Lens (IOLs) Placements
A study testing Horizontal placement of the intraocular lens in the capsular bag and Vertical placement of the intraocular lens in the capsular bag in people with Cataract and Pseudophakia, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Usually following cataract surgery patients would expect to have normal distance vision and not require the use of distance glasses. However, in clinical practice desired vision post cataract surgery is not achieved sometimes. In such cases a piggyback lens is used to enhance the visual outcome. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cataract, Pseudophakia
- What is being tested?
- Horizontal placement of the intraocular lens in the capsular bag and Vertical placement of the intraocular lens in the capsular bag
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Sep 2016to 5 Jan 2019
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cataracts undergoing cataract extraction in both eye.
- Diopters of corneal astigmatism Scheimpflug imaging (Pentacam HR, Oculus, Germany)
Who cannot join
- Less than 18 years
- Significant ophthalmic co-morbidity that may affect the anatomy of the eye
- Not competent to give fully informed consent
- Unable to have surgery and attend follow up appointment at Sussex Eye Hospital, Brighton
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brighton & Sussex University Hospitals NHS Trust
Brighton, Sussex, BN2 5BF
About this study
Official title: Fellow Eye Study Evaluating Correlation Between Sulcus Anatomy and Ocular Parameters Using Ultrasound Biomicroscopy (UBM) After Horizontal or Vertical Placement of the Intraocular Lens (IOLs) in the Capsular Bag
Usually following cataract surgery patients would expect to have normal distance vision and not require the use of distance glasses. However, in clinical practice desired vision post cataract surgery is not achieved sometimes. In such cases a piggyback lens is used to enhance the visual outcome. This lens is placed in the ciliary sulcus (space between the iris and the lens). Often this piggyback lens is not the best fit for the ciliary sulcus space and it moves. This study will be using ultrasound biomicroscopy to measure the ciliary sulcus dimensions pre and postoperatively to estimate the normal anatomy and it's variations. Patients in this study will be randomised as to which way the intraocular lens is placed in the eye (horizontally or vertically) at the time of their cataract surgery. Patients requiring cataract surgery in both eyes will be identified from the Eye Hospital at the Royal Sussex County Hospital. Patients will be in the study for up to 6 months from being identified as suitable through to the operation in the 2nd eye and a final study visit.
Read the detailed description
Study Design This is a prospective, fellow eye randomised study.
Recruitment
A sample size of 92 eyes (46 patients) was calculated. Patients will be recruited at the Sussex Eye Hospital preoperative cataract assessment clinics where they will be screened and given a patient information sheet by a member of the research team if they can be recruited. They will be allowed to take this home to discuss with their family/friends and/or GP. They will be asked if the research team could contact them in a weeks time to discuss the study and the plan for the day of their surgery (which is their next NHS visit). Patients can then agree or decline to participate in the study . If they decline, their normal NHS pathway will continue. If they accept, written informed consent will be taken on the day of surgery as well as any extra imaging required. The key points of the trial will be reiterated and the patient will be invited to ask any questions. All members of the research team are NIHR GCP trained. All research patients will undergo surgery by the same surgeon and attend for post-operative follow-up at the Sussex Eye Hospital. In addition at this visit a research appointment will be made to undertake the research scans and examinations (see details below) by an experienced member of our research team. The research team including the surgeon cannot be blinded as the obvious direction of placement of the intraocular lens will be visible during surgery and during examination.
Pre-operative appointment
Consent If the patient would like to participate they will be asked to read and sign a consent form. If the patient gives consent for their GP to be notified of their participation in the study a letter will be sent to the GP.
Standard pre-operative protocol for all NHS patients:
- Unaided and best corrected distance visual acuity
- Intraocular pressure measurement (applanation tonometry)
- Optical or ultrasound biometry for lens power calculation
- Slit lamp examination of the eye (by a doctor) including dilated fundus evaluation For non-standard (research) measurements, patients will be asked to return for a separate appointment. All measurements will be performed at ambient room light (undilated pupil).
The assessment will continue as follows:
- Scheimpflug scans (Pentacam)
- Anaesthesia of the eye with proxymetacaine 1%
- Measurement using digital calipers of the white-to-white diameter Carbomer gel will be applied to protect the cornea before application of ultrasound probe
- Contact ultrasound biomicroscopy images will be taken in 4 axes: vertical, horizontal, temporal oblique and nasal oblique. The patient will be asked to fixate with the fellow eye on a target to maintain fixation and avoid accommodation. The examination will be performed with undilated pupils.
Surgery
All surgery will be carried out by the same surgeon (Principal Investigator) who is an experienced senior Ophthalmic Surgeon. This is to avoid any surgery-induced study biases. Surgery will be performed employing a standardized technique with aspheric monofocal intraocular lenses. The eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL.
Non-standard (research)intervention post-operatively on the day of surgery:
Image taken with anterior segment ocular coherence tomography.
Standard post-operative protocol for all NHS patients at 4-6 weeks:
- Unaided and best corrected distance visual acuity 2) Intraocular pressure measurement (applanation tonometry) 3) Slit lamp examination of the eye Non-standard (research) post-operative measurements for patients enrolled in this study (performed at the time convenient to patient and the research team): All measurements will be performed at ambient room light (undilated pupil).
- Dilated retroillumination images of the IOL immediately postoperatively (ideally on the day of the surgery)
- Scheimpflug scans (Pentacam®) at 4-6 weeks
- Anaesthesia of the eye with proxymetacaine 1% at 4-6 weeks
- Carbomer gel will be applied to protect the cornea before application of ultrasound probe. The patient will be asked to fixate with the fellow eye on a target to maintain fixation and avoid accommodation. This examination performed with undilated pupils at 4-6 weeks.
- Contact ultrasound biomicroscopy images at 4-6 weeks will be taken in 4 axes: vertical, horizontal, temporal oblique and nasal oblique.
- Conditions
- Cataract, Pseudophakia
- Being tested
- Horizontal placement of the intraocular lens in the capsular bag, Vertical placement of the intraocular lens in the capsular bag
- Keywords
- cataract, pseudophakia, intraocular lens, ciliary sulcus, anatomy
- Medical subject headings
- Cataract, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal placement of the intraocular lens in the capsular bagProcedure or surgery
The eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL. the fellow eye will receive the opposite placement (horizontal or vertical) of the IOL.
Vertical placement of the intraocular lens in the capsular bagProcedure or surgery
The eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL. the fellow eye will receive the opposite placement (horizontal or vertical) of the IOL.
| Study group | Role | What they receive |
|---|---|---|
| Horizontal placement of the intraocular lens | Other | The eyes randomised to have horizontal placement of intraocular lenses Receives: Procedure: Horizontal placement of the intraocular lens in the capsular bag |
| Vertical placement of the intraocular lens | Other | Fellow eye receiving vertical placement of intraocular lens. Receives: Procedure: Vertical placement of the intraocular lens in the capsular bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sulcus diameter versus anterior chamber dimension
Correlations between sulcus diameter and anterior chamber dimensions in the 4 axes pre and post operatively and also for the differences post and pre operatively.
Measured: 1 month
Secondary outcomes (5)
Changes in sulcus diameter in 4 axes in eyes with vertical and horizontal placement of IOLs
Measured on UBM
Measured: 1 month
Changes in anterior chamber depth following cataract extraction
Measured on UBM and Pentacam
Measured: 1 month
Changes in anterior chamber diameter following cataract extraction
Measured on UBM and Pentacam
Measured: 1 month
Rotation of the IOL in degrees from it's primary placement at 4-6 weeks at postoperative follow up.
Measured on retro-illumination photographs
Measured: 1 month
To explore any relationship between demographics in relation to sulcus anatomy
Analysed from the demographics
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 posted23 Dec 2019
- Study start14 Sep 2016
- Primary completion5 Jan 2019
- Study completion5 Jan 2019
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fellow eye comparison when one eye has the intraocular lens placed in horizontal and other in vertical axis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mayank Nanavaty, Study chair, Brighton and Sussex University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208633
- Sponsor's protocol ID
- 145273
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nanavaty MA, Offer C, Kier C, Way C, Frattaroli P, Bremner S. Changes in the sulcus and anterior chamber after horizontal or vertical intraocular lens orientation: prospective randomized study. J Cataract Refract Surg. 2025 Nov 1;51(11):1011-1018. doi: 10.1097/j.jcrs.0000000000001727.
PubMed 40601404
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fellow Eye Study Evaluating Correlation Between Sulcus Anatomy and Ocular Parameters Using Ultrasound Biomicroscopy (UBM) After Horizontal or Vertical Placement of the Intraocular Lens (IOLs) in the Capsular Bag
- ClinicalTrials.gov ID
- NCT04208633
- Acronym / sponsor ID
- 145273
- Conditions
- Cataract, Pseudophakia
- Keywords
- cataract, pseudophakia, intraocular lens, ciliary sulcus, anatomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 5 Jan 2019 (actual)
- Study completion
- 5 Jan 2019 (actual)
- First posted
- 23 Dec 2019 (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.
Usually following cataract surgery patients would expect to have normal distance vision and not require the use of distance glasses. However, in clinical practice desired vision post cataract surgery is not achieved sometimes. In such cases a piggyback lens is used to enhance the visual outcome. This lens is placed in the ciliary sulcus (space between the iris and the lens). Often this piggyback lens is not the best fit for the ciliary sulcus space and it moves. This study will be using ultrasound biomicroscopy to measure the ciliary sulcus dimensions pre and postoperatively to estimate the normal anatomy and it's variations. Patients in this study will be randomised as to which way the intraocular lens is placed in the eye (horizontally or vertically) at the time of their cataract surgery. Patients requiring cataract surgery in both eyes will be identified from the Eye Hospital at the Royal Sussex County Hospital. Patients will be in the study for up to 6 months from being identified as suitable through to the operation in the 2nd eye and a final study visit.
Detailed description
Study Design This is a prospective, fellow eye randomised study.
Recruitment
A sample size of 92 eyes (46 patients) was calculated. Patients will be recruited at the Sussex Eye Hospital preoperative cataract assessment clinics where they will be screened and given a patient information sheet by a member of the research team if they can be recruited. They will be allowed to take this home to discuss with their family/friends and/or GP. They will be asked if the research team could contact them in a weeks time to discuss the study and the plan for the day of their surgery (which is their next NHS visit). Patients can then agree or decline to participate in the study . If they decline, their normal NHS pathway will continue. If they accept, written informed consent will be taken on the day of surgery as well as any extra imaging required. The key points of the trial will be reiterated and the patient will be invited to ask any questions. All members of the research team are NIHR GCP trained. All research patients will undergo surgery by the same surgeon and attend for post-operative follow-up at the Sussex Eye Hospital. In addition at this visit a research appointment will be made to undertake the research scans and examinations (see details below) by an experienced member of our research team. The research team including the surgeon cannot be blinded as the obvious direction of placement of the intraocular lens will be visible during surgery and during examination.
Pre-operative appointment
Consent If the patient would like to participate they will be asked to read and sign a consent form. If the patient gives consent for their GP to be notified of their participation in the study a letter will be sent to the GP.
Standard pre-operative protocol for all NHS patients:
- Unaided and best corrected distance visual acuity
- Intraocular pressure measurement (applanation tonometry)
- Optical or ultrasound biometry for lens power calculation
- Slit lamp examination of the eye (by a doctor) including dilated fundus evaluation For non-standard (research) measurements, patients will be asked to return for a separate appointment. All measurements will be performed at ambient room light (undilated pupil).
The assessment will continue as follows:
- Scheimpflug scans (Pentacam)
- Anaesthesia of the eye with proxymetacaine 1%
- Measurement using digital calipers of the white-to-white diameter Carbomer gel will be applied to protect the cornea before application of ultrasound probe
- Contact ultrasound biomicroscopy images will be taken in 4 axes: vertical, horizontal, temporal oblique and nasal oblique. The patient will be asked to fixate with the fellow eye on a target to maintain fixation and avoid accommodation. The examination will be performed with undilated pupils.
Surgery
All surgery will be carried out by the same surgeon (Principal Investigator) who is an experienced senior Ophthalmic Surgeon. This is to avoid any surgery-induced study biases. Surgery will be performed employing a standardized technique with aspheric monofocal intraocular lenses. The eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL.
Non-standard (research)intervention post-operatively on the day of surgery:
Image taken with anterior segment ocular coherence tomography.
Standard post-operative protocol for all NHS patients at 4-6 weeks:
- Unaided and best corrected distance visual acuity 2) Intraocular pressure measurement (applanation tonometry) 3) Slit lamp examination of the eye Non-standard (research) post-operative measurements for patients enrolled in this study (performed at the time convenient to patient and the research team): All measurements will be performed at ambient room light (undilated pupil).
- Dilated retroillumination images of the IOL immediately postoperatively (ideally on the day of the surgery)
- Scheimpflug scans (Pentacam®) at 4-6 weeks
- Anaesthesia of the eye with proxymetacaine 1% at 4-6 weeks
- Carbomer gel will be applied to protect the cornea before application of ultrasound probe. The patient will be asked to fixate with the fellow eye on a target to maintain fixation and avoid accommodation. This examination performed with undilated pupils at 4-6 weeks.
- Contact ultrasound biomicroscopy images at 4-6 weeks will be taken in 4 axes: vertical, horizontal, temporal oblique and nasal oblique.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Fellow eye comparison when one eye has the intraocular lens placed in horizontal and other in vertical axis.
| Arm | Type | Receives |
|---|---|---|
| Horizontal placement of the intraocular lens | Other | Procedure: Horizontal placement of the intraocular lens in the capsular bagThe eyes randomised to have horizontal placement of intraocular lenses |
| Vertical placement of the intraocular lens | Other | Procedure: Vertical placement of the intraocular lens in the capsular bagFellow eye receiving vertical placement of intraocular lens. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with cataracts undergoing cataract extraction in both eye.
- Diopters of corneal astigmatism Scheimpflug imaging (Pentacam HR, Oculus, Germany)
Key exclusion criteria (4 listed)
- Less than 18 years
- Significant ophthalmic co-morbidity that may affect the anatomy of the eye
- Not competent to give fully informed consent
- Unable to have surgery and attend follow up appointment at Sussex Eye Hospital, Brighton
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 |
|---|---|---|
| Horizontal placement of the intraocular lens in the capsular bagThe eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL. the fellow eye will receive the opposite placement (horizontal or vertical) of the IOL. | Procedure or surgery | Horizontal placement of the intraocular lens |
| Vertical placement of the intraocular lens in the capsular bagThe eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL. the fellow eye will receive the opposite placement (horizontal or vertical) of the IOL. | Procedure or surgery | Vertical placement of the intraocular lens |
Primary outcome
Sulcus diameter versus anterior chamber dimension
Time frame: 1 month
Correlations between sulcus diameter and anterior chamber dimensions in the 4 axes pre and post operatively and also for the differences post and pre operatively.
5 secondary outcomes
Changes in sulcus diameter in 4 axes in eyes with vertical and horizontal placement of IOLs
Time frame: 1 month
Changes in anterior chamber depth following cataract extraction
Time frame: 1 month
Changes in anterior chamber diameter following cataract extraction
Time frame: 1 month
Rotation of the IOL in degrees from it's primary placement at 4-6 weeks at postoperative follow up.
Time frame: 1 month
To explore any relationship between demographics in relation to sulcus anatomy
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Derived from this study: PubMed 40601404Nanavaty MA, Offer C, Kier C, Way C, Frattaroli P, Bremner S. Changes in the sulcus and anterior chamber after horizontal or vertical intraocular lens orientation: prospective randomized study. J Cataract Refract Surg. 2025 Nov 1;51(11):1011-1018. doi: 10.1097/j.jcrs.0000000000001727.
- Health Research Authority UKLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mayank Nanavaty study chair
Brighton and Sussex University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizontal placement of the intraocular lens in the capsular bag and Vertical placement of the intraocular lens in the capsular bag in people with Cataract and Pseudophakia, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 23 Dec 2019. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sulcus diameter versus anterior chamber dimension (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 NCT04208633, which also lists 1 linked publication.
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 23 Dec 2019.