: study to access laser to posterior capsule in laser assisted cataract surgery patients
- Conditions
- Unspecified age-related cataract,
- Registration Number
- CTRI/2025/04/085605
- Lead Sponsor
- Nethradhama Super Speciality Eye Hospital
- Brief Summary
InstitutionalEthics committee approval will be obtained and trial registered with ClinicalTrial Registry of India. Patients informed consent will be taken and theprocedure explained to them in their own language.
During theproposed pilot phase, a group undergoing FLACS with systematic posteriorcapsulotomy with the Femtosecond Laser Femto LDV Z8 (Ziemer Ophthalmic SystemsAG, Port, Switzerland) will be compared to a control group undergoing FLACSwithout posterior capsulotomy.
*Studydesign*: prospective, pilot, randomized,comparative, hospital-based, single centerinterventional clinical study
*StudyPopulation:* Patientsundergoing cataract surgery (FLACS) with PrimaryPosterior Capsulotomy with FemtoLDV Z8.
*StudySetting:* Nethradhama Superspeciality Eye Hospital,Bangalore*.*
*Patient selectioncriteria:*Patientswill be enrolled into the clinical study and randomized in a ratio of 1:1 in a sequentialmanner as per the discretion of the Investigator. The patients will also bewilling to attend routine follow-up care as describedbelow (1 day up to 6 weeks post-surgery).
*Study Duration:* Time frame for patient visits and examinationare pre-operative, day of surgery, postoperative days 1, 14, and 45 days
Before the surgery,all patients will undergo a complete ophthalmic examination including UVCA BCVAmanifest refraction, slit lamp biomicroscopy, noncontact tonometry (TopconCT-80), and macular OCT(Optovue, Fremont, USA) AS OCT and dilated fundus examination.
*Surgical procedure:*
Patients willundergo monocular FLACS with the Femto LDV Z8. At random, a patient to betreated will be assigned to the control group or to the group where posteriorcapsulotomy will be performed using the Femto LDV Z8.
In both groups, the laser will be used toperform anterior capsulotomy and corneal incisions. The surgery algorithm upuntil to the point at which the IOL is implanted does not differ between thegroups. The surgeon will then ensure the corneal incisions are sealing theanterior chamber. Surgeon will place a small amount of viscoelastic between theIOL and the posterior capsule to prevent IOL damage.
For those eyes assigned to the posteriorcapsulotomy group, the suction ring of the laser will be docked. After suctionis achieved, the surgeon checks again that the corneal incision is sealed.After docking the handpiece of the Femto LDV Z8, the surgeon will grade thevisibility of the anterior hyaloid on a scale from 0 to 3, where 0 correspondsto no visibility of the anterior hyaloid and 3 corresponds to excellentvisibility of the entire Berger Space. The surgeon will then ensure that thecut placement of the posterior capsulotomy is in accordance with the surgicalplan. In case satisfying placement of the posterior capsulotomy is notpossible, suction will be aborted and the eye will drop out of the study.
After the cut, the surgeon will grade thecut quality of the posterior capsulotomy based on the following criteria:
1. **Taggingor incomplete cuts:** The surgeon will gradethe cut quality on a scale ranging from 0 to 3, defined the following way:
a. Value0 corresponds to a partial cut which is impossible to remove manually
b. Value1 corresponds to a circular cut with tags or uncut areas, but it is stillpossible to remove manually
c. Value2 corresponds to a complete cut with filaments.
d. Value3 corresponds to a complete circular cut with a free-floating posteriorcapsulotomy
2. **CapsulotomyDiameter Accuracy:** The surgeon measures the diameter of theposterior capsulotomy. This value will then be compared to the planned value.In case of an elliptic shape, the surgeon will measure both major axes.
3. **EdgeQuality:** Surgeon will grade smoothness on a scaleranging from 0 to 3, defined the following way:
a. Grade0 corresponds to significant irregularities with pronounced jagged or tornedges
b. Grade1 corresponds to moderate irregularities with some jagged edges
c. Grade2 corresponds to minor irregularities which will not affect the visual outcome
d. Grade3 corresponds to a perfectly smooth edge
Finally, the surgeon will use theirrigation/aspiration probe of the phacoemulsifier to remove the posteriorcapsulotomy if possible.
*Method of datacollection:*
Data will be collectedon the demographic profile (age, gender, address, and occupation) and ocularparameters of the patients, as measured by slit lamp examination, 90D lens withslit lamp, and indirect ophthalmoscopy.
Before the surgery,all patients will undergo a complete ophthalmic examination including UVCA BCVAmanifest refraction, slit lamp biomicroscopy, noncontact tonometry (TopconCT-80), and macular OCT(Optovue, Fremont, USA) AS OCT and dilated fundus examination
The following testswill be performed pre-operatively:
1. Detailed slit lamp and dilated fundusexamination
2. Uncorrected Distance Visual Acuity (UDVA)
3. Corrected Distance Visual Acuity (CDVA)
4. Manifest refraction
5. Non contact tonometry (Topcon CT-80 )
6. Macular OCT(Optovue, Fremont, USA)
7. AS OCT
Intra-operative data:
1. Total Operation time- from first incision to sealingthe wound
2. Effective Phaco Time- time from start of phaco tillcomplete nucleus removal
3. Amount of OVD injected posterior to IOL – in ml/cc
Post-operatively on day 1, 2 weeks, 6weeks thefollowing tests will be conducted.
1. Slit lamp examination
2. Uncorrected distance Visual Acuity(UDVA)
3. Corrected Distance Visual Acuity (CDVA)
4. Manifest refraction
5. Non contact tonometry (Topcon CT-80 )
6. Macular OCT(Optovue, Fremont, USA)
7. AS OCT (MS-39)- Evaluate IOL position and tilt
8. Dilated fundus examination was seen at 6 weeks
9. Subjective questionnaire
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
Age-related Cataract Best corrected Visual Acuity of not more than 6by 7.5 Nuclear Sclerotic Cataract Lens opacification which can be graded on the LOCS III scale with NC Grade 1 or higher (20) with cc and PSC Patients with eyes which are anatomically suitable to undergo FLACS with the Ziemer Femto LDV Z8.
Previous history of ocular pathologies, such as Age-related Macular Degeneration, Diabetic Retinopathy, any type of Glaucoma, Uveitis, Ocular Tumor Previous Ocular Surgery Corneal Opacities such as scars, ulcers, or related to endothelial dystrophy Pupil diameter of less than 6 mm or intraoperative floppy-iris syndrome Issues related to general health condition, such as uncontrolled diabetes, cardiovascular diseases, chronic kidney disease, uncontrolled hypertension Concurrent participation in another clinical study Weak zonules , subluxated Cataractous lens and PPC Operative complications, including posterior capsular tear, zonular dialysis, lens drop in vitreous.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method provide valuable insights into whether this approach could offer a safer alternative for managing PCO, thereby improving patient outcomes and expanding the preventive and therapeutic options available for cataract surgery patients and to optimize surgical and laser parameters and provide a first evaluation in terms of safety and efficacy. postoperative days 1, 14, and 45 days
- Secondary Outcome Measures
Name Time Method ascertain occurrence of common complications in Nd:YAG posterior capsulotomy. postoperative days 1, 14, and 45 days
Trial Locations
- Locations (1)
Nethradhama Super Speciality Eye Hospital
🇮🇳Bangalore, KARNATAKA, India
Nethradhama Super Speciality Eye Hospital🇮🇳Bangalore, KARNATAKA, IndiaDrPavithra priyadarshini P RPrincipal investigator9591723727prpavithrapriyadarshini@gmail.com